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    Clinical Trial Results:
    A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea

    Summary
    EudraCT number
    2008-005625-11
    Trial protocol
    DE   IT  
    Global end of trial date
    18 Nov 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Sep 2016
    First version publication date
    26 Jun 2015
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Bayer sponsor contact information to be updated

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-5027/91781
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00909857
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to show superiority of SH T00658ID over SH D593B with respect to the number of days with dysmenorrheic pain (defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode) in a defined period, i.e. comparison between two treatment cycles and two baseline cycles.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Only after the subject voluntarily signed the informed consent form was he/she able to enter the study. If the subject was not capable of providing a signature, an oral statement of consent could have been given in the presence of a witness. Each subject was assured of the right to withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Apr 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 96
    Country: Number of subjects enrolled
    Italy: 59
    Country: Number of subjects enrolled
    Chile: 53
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Philippines: 97
    Country: Number of subjects enrolled
    Germany: 148
    Worldwide total number of subjects
    464
    EEA total number of subjects
    207
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    24
    Adults (18-64 years)
    440
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.

    Pre-assignment
    Screening details
    Out of 771 subjects screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 subjects were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel), out of which 464 subjects received treatment.

    Period 1
    Period 1 title
    Overall Study
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Subject, Investigator
    Blinding implementation details
    For blinding purposes, a double-dummy design was used. The investigational and reference product were packed for a double-dummy design in one wallet with two blisters of 28 tablets each.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Arm description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo Match to SH T00658ID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

    Investigational medicinal product name
    Estradiol Valerate, Dienogest (SH T00658ID)
    Investigational medicinal product code
    BAY86-5027
    Other name
    Natazia, Qlaira
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

    Arm title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Arm description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
    Arm type
    Active comparator

    Investigational medicinal product name
    Placebo Match to SH D593B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.

    Investigational medicinal product name
    Ethinyl Estradiol, Levonorgestrel (SH D593B)
    Investigational medicinal product code
    Other name
    Miranova
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.

    Number of subjects in period 1
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Started
    253
    254
    Treated
    234
    230
    Completed
    217
    209
    Not completed
    36
    45
         Protocol violation
    2
    1
         Adverse event
    5
    5
         Unknown
    1
    -
         Pregnancy
    1
    -
         Consent withdrawn by subject
    6
    10
         Did not receive study medication
    19
    24
         Lost to follow-up
    2
    5
    Period 2
    Period 2 title
    Baseline period
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Arm description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.
    Arm type
    Experimental

    Investigational medicinal product name
    Estradiol Valerate, Dienogest (SH T00658ID)
    Investigational medicinal product code
    BAY86-5027
    Other name
    Natazia, Qlaira
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

    Investigational medicinal product name
    Placebo Match to SH T00658ID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

    Arm title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Arm description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ethinyl Estradiol, Levonorgestrel (SH D593B)
    Investigational medicinal product code
    Other name
    Miranova
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.

    Investigational medicinal product name
    Placebo Match to SH D593B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: In overall trial, all subjects who were randomized were included and the baseline characteristics were provided only for subjects who were treated. Hence, the baseline period of treated subjects was created to publish the baseline characteristics data.
    Number of subjects in period 2
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Started
    234
    230
    Completed
    234
    230

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Reporting group description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Reporting group title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Reporting group description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Reporting group values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova) Total
    Number of subjects
    234 230 464
    Age categorical
    Units: Subjects
        less than 18 years of age
    11 13 24
        18 years of age or older
    223 217 440
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28 ± 7.9 27.6 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    234 230 464

    End points

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    End points reporting groups
    Reporting group title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Reporting group description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

    Reporting group title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Reporting group description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
    Reporting group title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Reporting group description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Reporting group title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Reporting group description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available were included in the FAS.

    Primary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
    End point description
    Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Primary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) versus (vs) treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [1]
    219 [2]
    Units: days
        arithmetic mean (standard deviation)
    -4.6 ± 4.6
    -4.2 ± 4.2
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    An individual absolute change in days with dysmenorrheic pain from pretreatment was evaluated as number of days with dysmenorrheic pain during the treatment evaluation period minus number of days with dysmenorrheic pain during the pretreatment evaluation period.
    Comparison groups
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) v Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3358
    Method
    t-test, 2-sided
    Parameter type
    Difference of mean changes from baseline
    Point estimate
    -0.404
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.227
         upper limit
    0.4196

    Secondary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
    End point description
    Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference minimum -168 (best), maximum 168 (worst).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [3]
    219 [4]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -10.6 ± 9.7
    -10 ± 8.9
    Notes
    [3] - FAS
    [4] - FAS
    No statistical analyses for this end point

    Secondary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
    End point description
    Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [5]
    219 [6]
    Units: days
        arithmetic mean (standard deviation)
    -4 ± 5.7
    -3.7 ± 5.7
    Notes
    [5] - FAS
    [6] - FAS
    No statistical analyses for this end point

    Secondary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
    End point description
    Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [7]
    219 [8]
    Units: days
        arithmetic mean (standard deviation)
    0.3 ± 2.6
    0.1 ± 2
    Notes
    [7] - FAS
    [8] - FAS
    No statistical analyses for this end point

    Secondary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
    End point description
    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [9]
    219 [10]
    Units: tablets
        arithmetic mean (standard deviation)
    -6.2 ± 14.8
    -6.6 ± 12.3
    Notes
    [9] - FAS
    [10] - FAS
    No statistical analyses for this end point

    Secondary: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)

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    End point title
    Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
    End point description
    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [11]
    219 [12]
    Units: tablets
        arithmetic mean (standard deviation)
    -4.5 ± 19.9
    -5.6 ± 14.3
    Notes
    [11] - FAS
    [12] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)

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    End point title
    Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
    End point description
    Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [13]
    230 [14]
    Units: percentage of subjects
    number (not applicable)
        Baseline period-daily activities impaired
    92.3
    91.3
        Baseline period- leisure activities impaired
    90.6
    89.6
        Treatment period-daily activities impaired
    51.7
    56.5
        Treatment period- leisure activities impaired
    47.9
    56.5
    Notes
    [13] - FAS
    [14] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)

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    End point title
    Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
    End point description
    Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
    End point type
    Secondary
    End point timeframe
    Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [15]
    230 [16]
    Units: percentage of subjects
    number (not applicable)
        Baseline period-daily activities impaired
    93.2
    92.2
        Baseline period- leisure activities impaired
    92.3
    90
        Treatment period-daily activities impaired
    54.7
    60
        Treatment period- leisure activities impaired
    52.6
    61.3
    Notes
    [15] - FAS
    [16] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Satisfied With Study Treatment

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    End point title
    Percentage of Subjects Satisfied With Study Treatment
    End point description
    Subjects were asked to express the degree of their satisfaction with study treatment.
    End point type
    Secondary
    End point timeframe
    From cycle 1 to cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    225 [17]
    216 [18]
    Units: percentage of subjects
    number (not applicable)
        Missing
    0.9
    1.3
        Very satisfied
    53.4
    50.4
        Satisfied
    32.1
    30
        Neither satisfied nor dissatisfied
    7.3
    8.3
        Dissatisfied
    2.1
    3.5
        Very dissatisfied
    0.4
    0.4
    Notes
    [17] - FAS
    [18] - FAS
    No statistical analyses for this end point

    Secondary: Number of Days With Bleeding or Spotting

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    End point title
    Number of Days With Bleeding or Spotting
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [19]
    197 [20]
    Units: days
        arithmetic mean (standard deviation)
    20 ± 8.8
    23.6 ± 9.7
    Notes
    [19] - FAS
    [20] - FAS
    No statistical analyses for this end point

    Secondary: Number of Episodes With Bleeding or Spotting

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    End point title
    Number of Episodes With Bleeding or Spotting
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [21]
    197 [22]
    Units: episodes
        arithmetic mean (standard deviation)
    3.9 ± 1
    4.1 ± 0.8
    Notes
    [21] - FAS
    [22] - FAS
    No statistical analyses for this end point

    Secondary: Mean Length of Bleeding or Spotting Episodes

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    End point title
    Mean Length of Bleeding or Spotting Episodes
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [23]
    197 [24]
    Units: days
        arithmetic mean (standard deviation)
    5.17 ± 2.26
    5.83 ± 2.35
    Notes
    [23] - FAS
    [24] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Length of Bleeding or Spotting Episodes

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    End point title
    Maximum Length of Bleeding or Spotting Episodes
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [25]
    197 [26]
    Units: days
        arithmetic mean (standard deviation)
    7.1 ± 3.8
    8.4 ± 5.6
    Notes
    [25] - FAS
    [26] - FAS
    No statistical analyses for this end point

    Secondary: Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode

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    End point title
    Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [27]
    197 [28]
    Units: days
        arithmetic mean (standard deviation)
    3.6 ± 3.6
    4.6 ± 5.6
    Notes
    [27] - FAS
    [28] - FAS
    No statistical analyses for this end point

    Secondary: Number of Days With Spotting-only

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    End point title
    Number of Days With Spotting-only
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [29]
    197 [30]
    Units: days
        arithmetic mean (standard deviation)
    7.3 ± 6.9
    7.6 ± 7.5
    Notes
    [29] - FAS
    [30] - FAS
    No statistical analyses for this end point

    Secondary: Number of Episodes With Spotting-only

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    End point title
    Number of Episodes With Spotting-only
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    201 [31]
    197 [32]
    Units: episodes
        arithmetic mean (standard deviation)
    0.5 ± 0.8
    0.4 ± 0.7
    Notes
    [31] - FAS
    [32] - FAS
    No statistical analyses for this end point

    Secondary: Mean Length of Spotting Only Episodes

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    End point title
    Mean Length of Spotting Only Episodes
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    67 [33]
    51 [34]
    Units: days
        arithmetic mean (standard deviation)
    3.29 ± 2.39
    3.26 ± 2.79
    Notes
    [33] - FAS
    [34] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Length of Spotting Only Episodes

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    End point title
    Maximum Length of Spotting Only Episodes
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    67 [35]
    51 [36]
    Units: days
        arithmetic mean (standard deviation)
    3.9 ± 3.1
    3.6 ± 3
    Notes
    [35] - FAS
    [36] - FAS
    No statistical analyses for this end point

    Secondary: Difference in Duration Between Longest and Shortest Spotting Only Episode

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    End point title
    Difference in Duration Between Longest and Shortest Spotting Only Episode
    End point description
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 90
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    67 [37]
    51 [38]
    Units: days
        arithmetic mean (standard deviation)
    1.2 ± 2.5
    0.7 ± 1.5
    Notes
    [37] - FAS
    [38] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Withdrawal Bleeding at Cycle 1

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    End point title
    Percentage of Subjects With Withdrawal Bleeding at Cycle 1
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [39]
    222 [40]
    Units: percentage of subjects
        number (not applicable)
    91.2
    93.2
    Notes
    [39] - FAS
    [40] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Withdrawal Bleeding at Cycle 3

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    End point title
    Percentage of Subjects With Withdrawal Bleeding at Cycle 3
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    204 [41]
    198 [42]
    Units: percentage of subjects
        number (not applicable)
    68.1
    79.3
    Notes
    [41] - FAS
    [42] - FAS
    No statistical analyses for this end point

    Secondary: Length of Withdrawal Bleeding Episodes at Cycle 1

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    End point title
    Length of Withdrawal Bleeding Episodes at Cycle 1
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    206 [43]
    207 [44]
    Units: days
        arithmetic mean (standard deviation)
    5.2 ± 2.7
    5.4 ± 2.4
    Notes
    [43] - FAS
    [44] - FAS
    No statistical analyses for this end point

    Secondary: Length of Withdrawal Bleeding Episodes at Cycle 3

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    End point title
    Length of Withdrawal Bleeding Episodes at Cycle 3
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    139 [45]
    157 [46]
    Units: days
        arithmetic mean (standard deviation)
    4.5 ± 1.7
    5.2 ± 2
    Notes
    [45] - FAS
    [46] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

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    End point title
    Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    206 [47]
    207 [48]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    3.7 ± 1
    4 ± 0.9
    Notes
    [47] - FAS
    [48] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

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    End point title
    Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    139 [49]
    157 [50]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    3.7 ± 0.8
    4.1 ± 0.8
    Notes
    [49] - FAS
    [50] - FAS
    No statistical analyses for this end point

    Secondary: Onset of Withdrawal Bleeding Episodes at Cycle 1

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    End point title
    Onset of Withdrawal Bleeding Episodes at Cycle 1
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    206 [51]
    207 [52]
    Units: days
        arithmetic mean (standard deviation)
    4.8 ± 7
    4.9 ± 5.9
    Notes
    [51] - FAS
    [52] - FAS
    No statistical analyses for this end point

    Secondary: Onset of Withdrawal Bleeding Episodes at Cycle 3

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    End point title
    Onset of Withdrawal Bleeding Episodes at Cycle 3
    End point description
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    139 [53]
    157 [54]
    Units: days
        arithmetic mean (standard deviation)
    3.1 ± 3.7
    4.3 ± 4.4
    Notes
    [53] - FAS
    [54] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Intracyclic Bleeding at Cycle 1

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    End point title
    Percentage of Subjects With Intracyclic Bleeding at Cycle 1
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [55]
    222 [56]
    Units: percentage of subjects
        number (not applicable)
    19
    16.7
    Notes
    [55] - FAS
    [56] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Intracyclic Bleeding at Cycle 3

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    End point title
    Percentage of Subjects With Intracyclic Bleeding at Cycle 3
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    204 [57]
    198 [58]
    Units: percentage of subjects
        number (not applicable)
    10.8
    11.6
    Notes
    [57] - FAS
    [58] - FAS
    No statistical analyses for this end point

    Secondary: Number of Intracyclic Bleeding Episodes at Cycle 1

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    End point title
    Number of Intracyclic Bleeding Episodes at Cycle 1
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [59]
    222 [60]
    Units: episodes
        arithmetic mean (standard deviation)
    0.2 ± 0.5
    0.2 ± 0.4
    Notes
    [59] - FAS
    [60] - FAS
    No statistical analyses for this end point

    Secondary: Number of Intracyclic Bleeding Episodes at Cycle 3

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    End point title
    Number of Intracyclic Bleeding Episodes at Cycle 3
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    204 [61]
    198 [62]
    Units: episodes
        arithmetic mean (standard deviation)
    0.1 ± 0.3
    0.1 ± 0.4
    Notes
    [61] - FAS
    [62] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

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    End point title
    Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    43 [63]
    37 [64]
    Units: days
        arithmetic mean (standard deviation)
    6 ± 5.4
    6.2 ± 5.7
    Notes
    [63] - FAS
    [64] - FAS
    No statistical analyses for this end point

    Secondary: Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

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    End point title
    Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    22 [65]
    23 [66]
    Units: days
        arithmetic mean (standard deviation)
    5.5 ± 4.7
    4.9 ± 4.1
    Notes
    [65] - FAS
    [66] - FAS
    No statistical analyses for this end point

    Secondary: Number of Intracyclic Bleeding Days at Cycle 1

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    End point title
    Number of Intracyclic Bleeding Days at Cycle 1
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [67]
    222 [68]
    Units: days
        arithmetic mean (standard deviation)
    1.2 ± 3.5
    1 ± 3.3
    Notes
    [67] - FAS
    [68] - FAS
    No statistical analyses for this end point

    Secondary: Number of Intracyclic Bleeding Days at Cycle 3

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    End point title
    Number of Intracyclic Bleeding Days at Cycle 3
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    204 [69]
    198 [70]
    Units: days
        arithmetic mean (standard deviation)
    0.6 ± 2.3
    0.6 ± 2.1
    Notes
    [69] - FAS
    [70] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

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    End point title
    Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
    End point type
    Secondary
    End point timeframe
    At cycle 1 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    43 [71]
    37 [72]
    Units: percentage of subjects
    number (not applicable)
        Spotting
    53.5
    62.2
        Light
    30.2
    10.8
        Normal
    9.3
    13.5
        Heavy
    7
    13.5
    Notes
    [71] - FAS
    [72] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

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    End point title
    Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
    End point description
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
    End point type
    Secondary
    End point timeframe
    At cycle 3 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    22 [73]
    23 [74]
    Units: percentage of subjects
    number (not applicable)
        Spotting
    45.5
    30.4
        Light
    27.3
    21.7
        Normal
    13.6
    30.4
        Heavy
    13.6
    17.4
    Notes
    [73] - FAS
    [74] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Screening

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    End point title
    Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Screening
    End point description
    The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
    End point type
    Secondary
    End point timeframe
    At screening (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [75]
    230 [76]
    Units: percentage of subjects
    number (not applicable)
        Missing
    0.4
    0
        Never
    38
    40.4
        4 working hours
    16.2
    16.1
        1 working day
    26.5
    29.6
        >= 2 working days
    18.8
    13.9
    Notes
    [75] - FAS
    [76] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle

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    End point title
    Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
    End point description
    The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
    End point type
    Secondary
    End point timeframe
    At Baseline (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [77]
    229 [78]
    Units: percentage of subjects
    number (not applicable)
        Missing
    0
    0
        Never
    47.9
    51.7
        4 working hours
    13.2
    11.7
        1 working day
    20.9
    23.9
        >= 2 working days
    17.9
    12.2
    Notes
    [77] - FAS
    [78] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2

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    End point title
    Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
    End point description
    The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
    End point type
    Secondary
    End point timeframe
    At cycle 2 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    224 [79]
    212 [80]
    Units: percentage of subjects
    number (not applicable)
        Missing
    0
    0
        Never
    78.6
    72.6
        4 working hours
    8.5
    6.5
        1 working day
    6.4
    8.7
        >= 2 working days
    2.1
    4.3
    Notes
    [79] - FAS
    [80] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Final Examination

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    End point title
    Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
    End point description
    The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [81]
    217 [82]
    Units: percentage of subjects
    number (not applicable)
        Missing
    0.4
    0
        Never
    85.9
    85.2
        4 working hours
    5.6
    2.6
        1 working day
    3
    4.8
        >= 2 working days
    1.7
    1.7
    Notes
    [81] - FAS
    [82] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    173 [83]
    174 [84]
    Units: dollars
        median (full range (min-max))
    0 (0 to 0)
    0 (0 to 0)
    Notes
    [83] - FAS
    [84] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    206 [85]
    195 [86]
    Units: dollars
        median (full range (min-max))
    5.46 (0 to 30)
    5.04 (0 to 27.49)
    Notes
    [85] - FAS
    [86] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    173 [87]
    176 [88]
    Units: dollars
        median (full range (min-max))
    0 (0 to 65.45)
    0 (0 to 65.45)
    Notes
    [87] - FAS
    [88] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    172 [89]
    172 [90]
    Units: dollars
        median (full range (min-max))
    0 (0 to 60)
    0 (0 to 295.98)
    Notes
    [89] - FAS
    [90] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    174 [91]
    174 [92]
    Units: dollars
        median (full range (min-max))
    0 (0 to 150)
    0 (0 to 74)
    Notes
    [91] - FAS
    [92] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs ofmedical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    170 [93]
    170 [94]
    Units: dollars
        median (full range (min-max))
    0 (0 to 271.68)
    0 (0 to 98.17)
    Notes
    [93] - FAS
    [94] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their other own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    177 [95]
    175 [96]
    Units: dollars
        median (full range (min-max))
    0 (0 to 196.34)
    0 (0 to 110)
    Notes
    [95] - FAS
    [96] - FAS
    No statistical analyses for this end point

    Secondary: Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    183 [97]
    179 [98]
    Units: dollars
        median (full range (min-max))
    0 (0 to 30)
    0 (0 to 10)
    Notes
    [97] - FAS
    [98] - FAS
    No statistical analyses for this end point

    Secondary: Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire

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    End point title
    Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
    End point description
    The subjects were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
    End point type
    Secondary
    End point timeframe
    At screening (average over 3 months before screening)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    192 [99]
    194 [100]
    Units: dollars
        median (full range (min-max))
    0 (0 to 15)
    0 (0 to 42)
    Notes
    [99] - FAS
    [100] - FAS
    No statistical analyses for this end point

    Secondary: Subjects With Improvement in the Investigators' Assessment in the Clinical Global Impression

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    End point title
    Subjects With Improvement in the Investigators' Assessment in the Clinical Global Impression
    End point description
    The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the subjects' improvement during the course of the study.
    End point type
    Secondary
    End point timeframe
    At cycle 2 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    223 [101]
    210 [102]
    Units: subjects
        Missing
    0
    0
        Not assessed
    1
    1
        Very much improved
    63
    42
        Much improved
    87
    84
        Minimally improved
    49
    54
        No change
    17
    23
        Minimally worse
    6
    3
        Much worse
    0
    3
    Notes
    [101] - FAS
    [102] - FAS
    No statistical analyses for this end point

    Secondary: Subjects With Improvement in Subjects' Assessment in the Clinical Global Impression

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    End point title
    Subjects With Improvement in Subjects' Assessment in the Clinical Global Impression
    End point description
    The CGI is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Subjects were asked to rate their improvement during the course of the study.
    End point type
    Secondary
    End point timeframe
    At cycle 2 (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    223 [103]
    210 [104]
    Units: subjects
        Missing
    1
    0
        Not assessed
    1
    1
        Very much improved
    60
    46
        Much improved
    91
    75
        Minimally improved
    47
    57
        No change
    18
    24
        Minimally worse
    5
    4
        Much worse
    0
    3
    Notes
    [103] - FAS
    [104] - FAS
    No statistical analyses for this end point

    Secondary: Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36 version 1 (v1), a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [105]
    229 [106]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    90.2 ± 16.7
    89.6 ± 17.5
    Notes
    [105] - FAS
    [106] - FAS
    No statistical analyses for this end point

    Secondary: Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36 v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [107]
    217 [108]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    93.7 ± 14.2
    92.5 ± 15
    Notes
    [107] - FAS
    [108] - FAS
    No statistical analyses for this end point

    Secondary: Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [109]
    229 [110]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    78.85 ± 18.99
    77.35 ± 20.56
    Notes
    [109] - FAS
    [110] - FAS
    No statistical analyses for this end point

    Secondary: Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [111]
    217 [112]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    85.95 ± 19.09
    84.79 ± 17.36
    Notes
    [111] - FAS
    [112] - FAS
    No statistical analyses for this end point

    Secondary: Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [113]
    229 [114]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    73.6 ± 15.6
    72.6 ± 16.3
    Notes
    [113] - FAS
    [114] - FAS
    No statistical analyses for this end point

    Secondary: Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [115]
    217 [116]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    77.3 ± 14.9
    76.4 ± 14.7
    Notes
    [115] - FAS
    [116] - FAS
    No statistical analyses for this end point

    Secondary: Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [117]
    229 [118]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    62.6 ± 18
    62.2 ± 18.2
    Notes
    [117] - FAS
    [118] - FAS
    No statistical analyses for this end point

    Secondary: Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [119]
    217 [120]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    68.2 ± 17
    67.2 ± 16.8
    Notes
    [119] - FAS
    [120] - FAS
    No statistical analyses for this end point

    Secondary: General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [121]
    229 [122]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    75.8 ± 17.5
    72.7 ± 16.9
    Notes
    [121] - FAS
    [122] - FAS
    No statistical analyses for this end point

    Secondary: General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [123]
    217 [124]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    77.2 ± 17.9
    76.5 ± 16.6
    Notes
    [123] - FAS
    [124] - FAS
    No statistical analyses for this end point

    Secondary: Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [125]
    229 [126]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    77.8 ± 33.6
    79.4 ± 32.7
    Notes
    [125] - FAS
    [126] - FAS
    No statistical analyses for this end point

    Secondary: Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [127]
    217 [128]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    89.6 ± 23
    87.9 ± 25.9
    Notes
    [127] - FAS
    [128] - FAS
    No statistical analyses for this end point

    Secondary: Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [129]
    229 [130]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    81.91 ± 31.5
    79.18 ± 34.74
    Notes
    [129] - FAS
    [130] - FAS
    No statistical analyses for this end point

    Secondary: Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [131]
    217 [132]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    88.64 ± 26.36
    83.87 ± 30.28
    Notes
    [131] - FAS
    [132] - FAS
    No statistical analyses for this end point

    Secondary: Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle

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    End point title
    Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At baseline cycle (28 days per cycle)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    234 [133]
    229 [134]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    50.7 ± 24.4
    51.8 ± 23
    Notes
    [133] - FAS
    [134] - FAS
    No statistical analyses for this end point

    Secondary: Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination

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    End point title
    Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
    End point description
    The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
    End point type
    Secondary
    End point timeframe
    At final examination (28 days)
    End point values
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) Ethinyl Estradiol, Levonorgestrel (Miranova)
    Number of subjects analysed
    226 [135]
    217 [136]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    77 ± 21.5
    74 ± 22.1
    Notes
    [135] - FAS
    [136] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment period (on-treatment cycles 2 and 3, usually 56 days) up to end of study visit (visit 4, final examination, 28 days)
    Adverse event reporting additional description
    Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Ethinyl Estradiol, Levonorgestrel (Miranova)
    Reporting group description
    Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Reporting group title
    Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Reporting group description
    Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period.

    Serious adverse events
    Ethinyl Estradiol, Levonorgestrel (Miranova) Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 230 (0.87%)
    2 / 234 (0.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian torsion
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Helminthic infection
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Ethinyl Estradiol, Levonorgestrel (Miranova) Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 230 (53.04%)
    131 / 234 (55.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    34 / 230 (14.78%)
    32 / 234 (13.68%)
         occurrences all number
    55
    55
    Tension headache
         subjects affected / exposed
    9 / 230 (3.91%)
    14 / 234 (5.98%)
         occurrences all number
    43
    40
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    3 / 230 (1.30%)
    7 / 234 (2.99%)
         occurrences all number
    3
    7
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    2 / 230 (0.87%)
    5 / 234 (2.14%)
         occurrences all number
    7
    10
    Nausea
         subjects affected / exposed
    5 / 230 (2.17%)
    2 / 234 (0.85%)
         occurrences all number
    6
    2
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    9 / 230 (3.91%)
    7 / 234 (2.99%)
         occurrences all number
    9
    7
    Dysfunctional uterine bleeding
         subjects affected / exposed
    5 / 230 (2.17%)
    3 / 234 (1.28%)
         occurrences all number
    6
    4
    Dysmenorrhoea
         subjects affected / exposed
    82 / 230 (35.65%)
    87 / 234 (37.18%)
         occurrences all number
    210
    208
    Metrorrhagia
         subjects affected / exposed
    13 / 230 (5.65%)
    18 / 234 (7.69%)
         occurrences all number
    17
    28
    Cervix inflammation
         subjects affected / exposed
    4 / 230 (1.74%)
    9 / 234 (3.85%)
         occurrences all number
    4
    9
    Infections and infestations
    Influenza
         subjects affected / exposed
    5 / 230 (2.17%)
    2 / 234 (0.85%)
         occurrences all number
    5
    2
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 230 (3.04%)
    4 / 234 (1.71%)
         occurrences all number
    10
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2009
    Amendment 1 was globally implemented before the inclusion of the first subject in the study. As an adequate (re-)supply for the originally planned comparator (Alesse) was not considered feasible, Alesse was replaced by SH D593B (Miranova), and the originally intended encapsulation of tablets for blinding was replaced by a double-dummy design that was considered to have advantages for the subjects, study drug supply and the study as a whole.
    26 Aug 2009
    Amendment 2 was globally implemented to reflect revised rules to be observed in case of missed tablets to further improve readability. These revised rules had been submitted with the regulatory submission of SH T00658ID to the Food and Drug Administration (FDA) on 02 Jul 2009. In addition, according to the general recommendations for combined oral contraceptive users, the maximum age for smokers to be eligible for this study was changed from 30 to 35 years.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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