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    Clinical Trial Results:
    Multicenter, randomized, open-label, parallel-group study to evaluate user satisfaction with and tolerability of the low-dose levonorgestrel (LNG) intrauterine delivery system (IUS) with 12 µg LNG/day initial in vitro release rate (LCS12) in comparison to a combined oral contraceptive containing 30 µg ethinyl estradiol and 3 mg drospirenone (Yasmin®) in young nulliparous and parous women (18-29 years) over 18 months of use

    Summary
    EudraCT number
    2010-020181-21
    Trial protocol
    AT   BE   DE  
    Global end of trial date
    28 May 2014

    Results information
    Results version number
    v3(current)
    This version publication date
    07 Sep 2017
    First version publication date
    10 May 2015
    Other versions
    v1 , v2
    Version creation reason
    • New data added to full data set
    Update to include data reported in CSR amendment

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-5028/13362
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01254292
    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
    28 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate user satisfaction in young nulliparous and parous women (18-29 years of age) using LCS12 compared with young nulliparous and parous women using a combined oral contraceptive (COC) over a period of 18 months.
    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. Participating subjects signed informed consent form and could 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
    06 Jan 2011
    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
    Austria: 173
    Country: Number of subjects enrolled
    Belgium: 101
    Country: Number of subjects enrolled
    Germany: 171
    Country: Number of subjects enrolled
    United States: 122
    Worldwide total number of subjects
    567
    EEA total number of subjects
    445
    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)
    0
    Adults (18-64 years)
    567
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.

    Pre-assignment
    Screening details
    644 subjects were screened, of which 77 were screen failures and 567 were randomized, 282 subjects to LCS12 and 285 subjects to Yasmin. 279 subjects randomized to LCS12 while 281 subjects randomized to Yasmin received treatment and started comparative phase up to 18 months. 200 subjects randomized to LCS12 entered extension phase up to 36 months.

    Period 1
    Period 1 title
    Comparative Phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    LCS12 (Jaydess, BAY86-5028)
    Arm description
    Subjects received LCS12 for 18 months with optional extension to 36 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    BAY86-5028
    Other name
    Skyla, Jaydess
    Pharmaceutical forms
    Intrauterine delivery system
    Routes of administration
    Intrauterine use
    Dosage and administration details
    Subjects received LCS12 for 18 months with optional extension to 36 months.

    Arm title
    EE30/DRSP (Yasmin, BAY86-5131)
    Arm description
    Subjects received COC tablet Yasmin containing 30 microgram ethinyl estradiol (EE) and 3 milligram (mg) drospirenone (DRSP) for 18 months per 19 cycles.
    Arm type
    Active comparator

    Investigational medicinal product name
    EE30/DRSP (Yasmin)
    Investigational medicinal product code
    BAY86-5131
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received COC tablet Yasmin containing 30 microgram EE and 3 mg DRSP for 18 months per 19 cycles.

    Number of subjects in period 1
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Started
    282
    285
    Subjects Received Treatment
    279
    281
    Completed
    227
    204
    Not completed
    55
    81
         Consent withdrawn by subject
    20
    21
         Protocol violation
    1
    2
         Wish for pregnancy
    4
    6
         Pregnancy
    2
    6
         Adverse event
    25
    25
         Lost to follow-up
    3
    21
    Period 2
    Period 2 title
    LCS12 Extension Phase
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    LCS12 (Jaydess, BAY86-5028)
    Arm description
    Subjects received LCS12 for 18 months with optional extension to 36 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    BAY86-5028
    Other name
    Skyla, Jaydess
    Pharmaceutical forms
    Intrauterine delivery system
    Routes of administration
    Intrauterine use
    Dosage and administration details
    Subjects received LCS12 for 18 months with optional extension to 36 months.

    Number of subjects in period 2
    LCS12 (Jaydess, BAY86-5028)
    Started
    200
    Completed
    163
    Not completed
    37
         Consent withdrawn by subject
    7
         Wish for pregnancy
    14
         Other unknown
    4
         Pregnancy
    2
         Adverse event
    9
         Lost to follow-up
    1
    Period 3
    Period 3 title
    Baseline Period
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    LCS12 (Jaydess, BAY86-5028)
    Arm description
    Subjects received LCS12 for 18 months with optional extension to 36 months. Subjects who received treatment were included in baseline period.
    Arm type
    Experimental

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    BAY86-5028
    Other name
    Skyla, Jaydess
    Pharmaceutical forms
    Intrauterine delivery system
    Routes of administration
    Intrauterine use
    Dosage and administration details
    Subjects received LCS12 for 18 months with optional extension to 36 months.

    Arm title
    EE30/DRSP (Yasmin, BAY86-5131)
    Arm description
    Subjects received COC tablet Yasmin containing 30 microgram EE and 3 mg DRSP for 18 months per 19 cycles. Subjects who received treatment were included in baseline period.
    Arm type
    Active comparator

    Investigational medicinal product name
    EE30/DRSP (Yasmin)
    Investigational medicinal product code
    BAY86-5131
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received COC tablet Yasmin containing 30 microgram EE and 3 mg DRSP for 18 months per 19 cycles.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: All subjects randomized to the 2 treatment groups were included in Comparative Phase. Baseline Period was created only for publishing the baseline characteristics which were provided for the treated subjects.
    Number of subjects in period 3
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Started
    279
    281
    Completed
    279
    281

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    LCS12 (Jaydess, BAY86-5028)
    Reporting group description
    Subjects received LCS12 for 18 months with optional extension to 36 months. Subjects who received treatment were included in baseline period.

    Reporting group title
    EE30/DRSP (Yasmin, BAY86-5131)
    Reporting group description
    Subjects received COC tablet Yasmin containing 30 microgram EE and 3 mg DRSP for 18 months per 19 cycles. Subjects who received treatment were included in baseline period.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Not all randomized subjects were treated with study drugs. Hence, the worldwide number enrolled in the trial, which is the same as the number randomized, differs from the number of subjects reported in the baseline period.
    Reporting group values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131) Total
    Number of subjects
    279 281 560
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    279 281 560
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    23.7 ( 3 ) 23.9 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    279 281 560
    Number of births
    Units: Subjects
        Zero
    216 206 422
        One
    39 49 88
        Two
    19 24 43
        Three
    4 2 6
        Four
    1 0 1
    Subject analysis sets

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS included all randomized subjects who received treatment (i.e., who took at least one tablet of Yasmin or who had a successful or unsuccessful insertion attempt of LCS12). All subjects in the FAS were analyzed according to the treatment they actually received. The FAS population comprised of 560 subjects, including 279 subjects randomized to LCS12 and 281 subjects randomized to Yasmin.

    Subject analysis sets values
    Full analysis set (FAS)
    Number of subjects
    560
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
    560
    Number of births
    Units: Subjects
        Zero
        One
        Two
        Three
        Four

    End points

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    End points reporting groups
    Reporting group title
    LCS12 (Jaydess, BAY86-5028)
    Reporting group description
    Subjects received LCS12 for 18 months with optional extension to 36 months.

    Reporting group title
    EE30/DRSP (Yasmin, BAY86-5131)
    Reporting group description
    Subjects received COC tablet Yasmin containing 30 microgram ethinyl estradiol (EE) and 3 milligram (mg) drospirenone (DRSP) for 18 months per 19 cycles.
    Reporting group title
    LCS12 (Jaydess, BAY86-5028)
    Reporting group description
    Subjects received LCS12 for 18 months with optional extension to 36 months.
    Reporting group title
    LCS12 (Jaydess, BAY86-5028)
    Reporting group description
    Subjects received LCS12 for 18 months with optional extension to 36 months. Subjects who received treatment were included in baseline period.

    Reporting group title
    EE30/DRSP (Yasmin, BAY86-5131)
    Reporting group description
    Subjects received COC tablet Yasmin containing 30 microgram EE and 3 mg DRSP for 18 months per 19 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
    The FAS included all randomized subjects who received treatment (i.e., who took at least one tablet of Yasmin or who had a successful or unsuccessful insertion attempt of LCS12). All subjects in the FAS were analyzed according to the treatment they actually received. The FAS population comprised of 560 subjects, including 279 subjects randomized to LCS12 and 281 subjects randomized to Yasmin.

    Primary: Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)

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    End point title
    Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) [1]
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied. The overall satisfaction rate is the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Primary
    End point timeframe
    At 18 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since descriptive statistical analysis was only planned for this endpoint.
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    274 [2]
    260 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    82.1 (77.1 to 86.5)
    81.9 (76.7 to 86.4)
    Notes
    [2] - FAS (only subjects with at least one assessment of the overall satisfaction rating)
    [3] - FAS (only subjects with at least one assessment of the overall satisfaction rating)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rating by the 5-Point Likert Item at 6 Months

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    End point title
    Overall Satisfaction Rating by the 5-Point Likert Item at 6 Months
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    273 [4]
    260 [5]
    Units: percentage of subjects
    number (not applicable)
        Very Satisfied
    60.4
    48.1
        Satisfied
    27.5
    35.8
        Neither satisfied nor dissatisfied
    7.3
    9.6
        Dissatisfied
    1.8
    6.2
        Very Dissatisfied
    2.9
    0.4
    Notes
    [4] - FAS (only subjects with an assessment of overall satisfaction rating at 6 months)
    [5] - FAS (only subjects with an assessment of overall satisfaction rating at 6 months)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rating by the 5-Point Likert Item at 12 Months

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    End point title
    Overall Satisfaction Rating by the 5-Point Likert Item at 12 Months
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Secondary
    End point timeframe
    At 12 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    253 [6]
    238 [7]
    Units: percentage of subjects
    number (not applicable)
        Very Satisfied
    66.8
    45
        Satisfied
    22.9
    44.1
        Neither satisfied nor dissatisfied
    5.9
    5.9
        Dissatisfied
    4.3
    3.8
        Very Dissatisfied
    0
    1.3
    Notes
    [6] - FAS (only subjects with an assessment of overall satisfaction rating at 12 months)
    [7] - FAS (only subjects with an assessment of overall satisfaction rating at 12 months)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rating by the 5-Point Likert Item at 18 Months

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    End point title
    Overall Satisfaction Rating by the 5-Point Likert Item at 18 Months
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied. The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Secondary
    End point timeframe
    At 18 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    235 [8]
    217 [9]
    Units: percentage of subjects
    number (not applicable)
        Very Satisfied
    64.3
    52.5
        Satisfied
    25.1
    37.8
        Neither satisfied nor dissatisfied
    6.4
    6.9
        Dissatisfied
    3
    2.8
        Very Dissatisfied
    1.3
    0
    Notes
    [8] - FAS (only subjects with an assessment of overall satisfaction rating at 18 months)
    [9] - FAS (only subjects with an assessment of overall satisfaction rating at 18 months)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rating by the 5-Point Likert Item at End of Study (EOS)

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    End point title
    Overall Satisfaction Rating by the 5-Point Likert Item at End of Study (EOS)
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    268 [10]
    251 [11]
    Units: percentage of subjects
    number (not applicable)
        Very Satisfied
    58.6
    46.6
        Satisfied
    23.5
    35.1
        Neither satisfied nor dissatisfied
    8.6
    9.6
        Dissatisfied
    5.6
    7.6
        Very Dissatisfied
    3.7
    1.2
    Notes
    [10] - FAS (only subjects with an assessment of overall satisfaction rating at 18 months/EOS)
    [11] - FAS (only subjects with an assessment of overall satisfaction rating at 18 months/EOS)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rate at 6 Months (LOCF)

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    End point title
    Overall Satisfaction Rate at 6 Months (LOCF)
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied. The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    273 [12]
    260 [13]
    Units: percentage of subjects
        number (not applicable)
    87.9
    83.8
    Notes
    [12] - FAS (only subjects with an assessment of overall satisfaction rating at 6 months or before)
    [13] - FAS (only subjects with an assessment of overall satisfaction rating at 6 months or before)
    No statistical analyses for this end point

    Secondary: Overall Satisfaction Rate at 12 Months (LOCF)

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    End point title
    Overall Satisfaction Rate at 12 Months (LOCF)
    End point description
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied. The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
    End point type
    Secondary
    End point timeframe
    At 12 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    274 [14]
    260 [15]
    Units: percentage of subjects
        number (not applicable)
    84.3
    83.8
    Notes
    [14] - FAS (only subjects with an assessment of overall satisfaction rating at 12 months)
    [15] - FAS (only subjects with an assessment of overall satisfaction rating at 12 months)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Acceptability of the Administration of Study Treatment

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    End point title
    User Satisfaction – Acceptability of the Administration of Study Treatment
    End point description
    The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without inconvenience/discomfort (I/D), acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    263 [16]
    250 [17]
    Units: subjects
        Acceptable without I/D
    153
    186
        Acceptable with some I/D
    87
    46
        Not acceptable with moderate I/D
    11
    15
        Not acceptable with extreme I/D
    12
    3
    Notes
    [16] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [17] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Choices Upon Completion of the Study

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    End point title
    User Satisfaction – Choices Upon Completion of the Study
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    263 [18]
    248 [19]
    Units: subjects
        Continue with study treatment
    174
    122
        Use a different hormonal contraceptive
    34
    51
        Use a different contraceptive method
    17
    27
        Discontinue use of all types of contraceptive
    6
    14
        No need for contraceptive at this time
    5
    12
        Undecided
    27
    22
    Notes
    [18] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [19] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Amount of Menstrual Bleeding

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    End point title
    User Satisfaction – Amount of Menstrual Bleeding
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    260 [20]
    250 [21]
    Units: subjects
        Decreased
    80
    35
        Not Changed
    163
    207
        Increased
    17
    8
    Notes
    [20] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [21] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Satisfaction With Menstrual Bleeding Pattern

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    End point title
    User Satisfaction – Satisfaction With Menstrual Bleeding Pattern
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    263 [22]
    250 [23]
    Units: subjects
        Very satisfied
    101
    91
        Somewhat satisfied
    65
    84
        Neither satisfied nor dissatisfied
    48
    68
        Dissatisfied
    19
    4
        Very dissatisfied
    10
    1
        Not applicable
    20
    2
    Notes
    [22] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [23] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Frequency of Experiencing Unexpected Bleeding

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    End point title
    User Satisfaction – Frequency of Experiencing Unexpected Bleeding
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    263 [24]
    250 [25]
    Units: subjects
        Never
    145
    219
        Seldom
    92
    25
        Often
    17
    5
        Very Often
    9
    1
    Notes
    [24] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [25] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Satisfaction With Menstrual Bleeding Absence

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    End point title
    User Satisfaction – Satisfaction With Menstrual Bleeding Absence
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    130 [26]
    14 [27]
    Units: subjects
        Very satisfied
    96
    6
        Somewhat satisfied
    18
    0
        Neither satisfied nor dissatisfied
    14
    8
        Dissatisfied
    1
    0
        Very dissatisfied
    1
    0
    Notes
    [26] - FAS (only subjects with an assessment of this questions of the user satisfaction questionnaire)
    [27] - FAS (only subjects with an assessment of this questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment

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    End point title
    User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    259 [28]
    247 [29]
    Units: subjects
        Decreased
    118
    61
        Not changed
    102
    169
        Increased
    39
    17
    Notes
    [28] - FAS (only subjects with an assessment of this questions of the user satisfaction questionnaire)
    [29] - FAS (only subjects with an assessment of this questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Rating of Usual Menstrual Pain Intensity

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    End point title
    User Satisfaction – Rating of Usual Menstrual Pain Intensity
    End point description
    The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    261 [30]
    249 [31]
    Units: subjects
        None
    124
    82
        Mild
    78
    92
        Moderate
    43
    67
        Severe
    16
    8
    Notes
    [30] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [31] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at Screening - Composite Score

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    End point title
    EVAPIL-R Scores at Screening - Composite Score
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
    End point type
    Secondary
    End point timeframe
    At screening
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    273 [32]
    275 [33]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    0.9386 ( 0.8036 )
    0.8846 ( 0.8231 )
    Notes
    [32] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    [33] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at Screening - Bother Score

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    End point title
    EVAPIL-R Scores at Screening - Bother Score
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
    End point type
    Secondary
    End point timeframe
    At screening
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    273 [34]
    276 [35]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    0.5569 ( 0.4451 )
    0.5188 ( 0.4406 )
    Notes
    [34] - FAS (subjects with an assessment of the EVAPIL questionnaire where bother score could be calculated)
    [35] - FAS (subjects with an assessment of the EVAPIL questionnaire where bother score could be calculated)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at 6 Months

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    End point title
    EVAPIL-R Scores at 6 Months
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    252 [36]
    243 [37]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Composite score
    1.3187 ( 0.9888 )
    1.1537 ( 0.9947 )
        Bother score
    0.7364 ( 0.494 )
    0.655 ( 0.5148 )
    Notes
    [36] - FAS (subjects with an assessment of the EVAPIL questionnaire where the scores could be calculated)
    [37] - FAS (subjects with an assessment of the EVAPIL questionnaire where the scores could be calculated)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at 12 Months - Composite Score

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    End point title
    EVAPIL-R Scores at 12 Months - Composite Score
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. FAS included only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated.
    End point type
    Secondary
    End point timeframe
    At 12 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    229 [38]
    218 [39]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    1.4022 ( 1.0126 )
    1.0535 ( 0.8698 )
    Notes
    [38] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    [39] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at 12 Months - Bother Score

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    End point title
    EVAPIL-R Scores at 12 Months - Bother Score
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. FAS included only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated.
    End point type
    Secondary
    End point timeframe
    At 12 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    233 [40]
    218 [41]
    Units: scores on a scale
        arithmetic mean (standard deviation)
    0.7789 ( 0.512 )
    0.6015 ( 0.4663 )
    Notes
    [40] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    [41] - FAS (subjects with an assessment of the EVAPIL questionnaire where this score could be calculated)
    No statistical analyses for this end point

    Secondary: EVAPIL-R Scores at 18 Months/EOS

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    End point title
    EVAPIL-R Scores at 18 Months/EOS
    End point description
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. FAS included only subjects with an assessment of the EVAPIL questionnaire at 18 months/EOS where the scores could be calculated. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
    End point type
    Secondary
    End point timeframe
    At 18 months/EOS
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    260 [42]
    250 [43]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Composite score
    1.4804 ( 1.1926 )
    1.0246 ( 0.9546 )
        Bother score
    0.8113 ( 0.5765 )
    0.5908 ( 0.4836 )
    Notes
    [42] - FAS (subjects with an assessment of the EVAPIL questionnaire where the scores could be calculated)
    [43] - FAS (subjects with an assessment of the EVAPIL questionnaire where the scores could be calculated)
    No statistical analyses for this end point

    Secondary: Cumulative Drop-out Rate

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    End point title
    Cumulative Drop-out Rate
    End point description
    The drop-out rate was the amount of subjects that could not complete the study for various reasons. Overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates. '99999' indicates that the data were not appilcable for that specific reporting group. Extension phase was only for LCS12 group.
    End point type
    Secondary
    End point timeframe
    Up to 6, 12, 18, 24 and 36 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    279 [44]
    281 [45]
    Units: percentage of subjects
    number (not applicable)
        Up to 6 months
    7.53
    11.39
        Up to 12 months
    13.26
    21.71
        Up to 18 months
    18.64
    27.4
        Up to 24 months
    30.85
    99999
        Up to 36 months
    33.34
    99999
    Notes
    [44] - FAS
    [45] - FAS
    No statistical analyses for this end point

    Secondary: Pearl Index (PI)

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    End point title
    Pearl Index (PI)
    End point description
    The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution. '99999' indicates that the data were not appilcable for that specific reporting group. Extension phase was only for LCS12 group.
    End point type
    Secondary
    End point timeframe
    Up to 18, 24, 36 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    279 [46]
    281 [47]
    Units: pregnancies per 100 women years
    arithmetic mean (confidence interval 95%)
        Pearl index up to 18 months
    0.57 (0.07 to 2.05)
    1.82 (0.67 to 3.97)
        Pearl index up to 24 months
    0.67 (0.14 to 1.95)
    99999 (99999 to 99999)
        Pearl index up to 36 months
    0.65 (0.18 to 1.67)
    99999 (99999 to 99999)
    Notes
    [46] - FAS
    [47] - FAS
    No statistical analyses for this end point

    Secondary: Compliance Rate for Yasmin Pill Intake

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    End point title
    Compliance Rate for Yasmin Pill Intake
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 18 months
    End point values
    EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    281 [48]
    Units: percentage of subjects
    number (not applicable)
        Missing
    2.8
        Compliance <=75%
    2.1
        Compliance >75%
    95
    Notes
    [48] - FAS
    No statistical analyses for this end point

    Secondary: User Satisfaction – Acceptability of the Administration of Study Treatment

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    End point title
    User Satisfaction – Acceptability of the Administration of Study Treatment
    End point description
    The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    256 [49]
    244 [50]
    Units: subjects
        Acceptable without I/D
    163
    192
        Acceptable with some I/D
    87
    48
        Not acceptable with moderate I/D
    4
    4
        Not acceptable with extreme I/D
    2
    0
    Notes
    [49] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [50] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Secondary: User Satisfaction – Acceptability of the Administration of Study Treatment

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    End point title
    User Satisfaction – Acceptability of the Administration of Study Treatment
    End point description
    The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
    End point type
    Secondary
    End point timeframe
    At 12 months
    End point values
    LCS12 (Jaydess, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
    Number of subjects analysed
    237 [51]
    220 [52]
    Units: subjects
        Acceptable without I/D
    152
    185
        Acceptable with some I/D
    74
    33
        Not acceptable with moderate I/D
    9
    2
        Not acceptable with extreme I/D
    1
    0
    Notes
    [51] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    [52] - FAS (only subjects with an assessment of these questions of the user satisfaction questionnaire)
    No statistical analyses for this end point

    Other pre-specified: Cumulative Number of Subjects With Partial or Total Expulsion

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    End point title
    Cumulative Number of Subjects With Partial or Total Expulsion
    End point description
    Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.
    End point type
    Other pre-specified
    End point timeframe
    Up to 18, 24, 36 months
    End point values
    LCS12 (Jaydess, BAY86-5028)
    Number of subjects analysed
    279 [53]
    Units: subjects
        Partial expulsion up to 18 months
    0
        Total expulsion up to 18 months
    0
        Partial expulsion up to 24 months
    1
        Total expulsion up to 24 months
    0
        Partial expulsion up to 36 months
    1
        Total expulsion up to 36 months
    0
    Notes
    [53] - FAS
    No statistical analyses for this end point

    Other pre-specified: Investigator's Evaluation of Successful IUS Insertion Procedure

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    End point title
    Investigator's Evaluation of Successful IUS Insertion Procedure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 18 months
    End point values
    LCS12 (Jaydess, BAY86-5028)
    Number of subjects analysed
    279 [54]
    Units: subjects
        Easy
    247
        Slightly difficult
    31
        Very difficult
    1
    Notes
    [54] - FAS
    No statistical analyses for this end point

    Other pre-specified: Subjects’ Evaluation of Pain During Successful IUS Insertion Procedure

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    End point title
    Subjects’ Evaluation of Pain During Successful IUS Insertion Procedure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 18 months
    End point values
    LCS12 (Jaydess, BAY86-5028)
    Number of subjects analysed
    279 [55]
    Units: subjects
        None
    49
        Mild
    125
        Moderate
    80
        Severe
    25
    Notes
    [55] - FAS
    No statistical analyses for this end point

    Other pre-specified: Investigator's Evaluation of IUS Removal Procedure

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    End point title
    Investigator's Evaluation of IUS Removal Procedure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 36 months
    End point values
    LCS12 (Jaydess, BAY86-5028)
    Number of subjects analysed
    267 [56]
    Units: subjects
        Easy
    252
        Slightly difficult
    11
        Very difficult
    4
    Notes
    [56] - FAS (only subjects in the LCS12 arm with documented removal of the IUS)
    No statistical analyses for this end point

    Other pre-specified: Subjects’ Evaluation of Pain During IUS Removal Procedure

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    End point title
    Subjects’ Evaluation of Pain During IUS Removal Procedure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 36 months
    End point values
    LCS12 (Jaydess, BAY86-5028)
    Number of subjects analysed
    267 [57]
    Units: subjects
        None
    136
        Mild
    96
        Moderate
    30
        Severe
    5
    Notes
    [57] - FAS (only subjects in the LCS12 arm with documented removal of the IUS)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment until 36 months/EOS visit.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    EE30/DRSP (Yasmin, BAY86-5131)
    Reporting group description
    Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 micron ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles.

    Reporting group title
    LCS12 (Skyla, BAY86-5028)
    Reporting group description
    Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 micron LNG per day for 18 months with optional extension to 36 months.

    Serious adverse events
    EE30/DRSP (Yasmin, BAY86-5131) LCS12 (Skyla, BAY86-5028)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 281 (1.78%)
    22 / 279 (7.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Borderline ovarian tumour
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma stage 0
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 281 (0.00%)
    2 / 279 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Breast prosthesis implantation
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mammoplasty
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myomectomy
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast fibrosis
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nose deformity
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    0 / 281 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 281 (0.71%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 281 (0.36%)
    0 / 279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    EE30/DRSP (Yasmin, BAY86-5131) LCS12 (Skyla, BAY86-5028)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    148 / 281 (52.67%)
    215 / 279 (77.06%)
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    1 / 281 (0.36%)
    5 / 279 (1.79%)
         occurrences all number
    1
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 281 (0.71%)
    3 / 279 (1.08%)
         occurrences all number
    2
    3
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 281 (0.36%)
    3 / 279 (1.08%)
         occurrences all number
    1
    3
    Breast tenderness
         subjects affected / exposed
    2 / 281 (0.71%)
    3 / 279 (1.08%)
         occurrences all number
    2
    3
    Cervical dysplasia
         subjects affected / exposed
    16 / 281 (5.69%)
    35 / 279 (12.54%)
         occurrences all number
    17
    44
    Dysmenorrhoea
         subjects affected / exposed
    26 / 281 (9.25%)
    47 / 279 (16.85%)
         occurrences all number
    73
    76
    Dyspareunia
         subjects affected / exposed
    0 / 281 (0.00%)
    4 / 279 (1.43%)
         occurrences all number
    0
    4
    Menorrhagia
         subjects affected / exposed
    5 / 281 (1.78%)
    6 / 279 (2.15%)
         occurrences all number
    5
    6
    Metrorrhagia
         subjects affected / exposed
    1 / 281 (0.36%)
    10 / 279 (3.58%)
         occurrences all number
    1
    14
    Ovarian cyst
         subjects affected / exposed
    0 / 281 (0.00%)
    18 / 279 (6.45%)
         occurrences all number
    0
    22
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 281 (0.00%)
    4 / 279 (1.43%)
         occurrences all number
    0
    4
    Pelvic pain
         subjects affected / exposed
    0 / 281 (0.00%)
    13 / 279 (4.66%)
         occurrences all number
    0
    15
    Vaginal discharge
         subjects affected / exposed
    0 / 281 (0.00%)
    12 / 279 (4.30%)
         occurrences all number
    0
    12
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 281 (0.00%)
    8 / 279 (2.87%)
         occurrences all number
    0
    8
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 281 (0.36%)
    3 / 279 (1.08%)
         occurrences all number
    2
    3
    Genital haemorrhage
         subjects affected / exposed
    0 / 281 (0.00%)
    6 / 279 (2.15%)
         occurrences all number
    0
    8
    Coital bleeding
         subjects affected / exposed
    1 / 281 (0.36%)
    5 / 279 (1.79%)
         occurrences all number
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 281 (1.07%)
    2 / 279 (0.72%)
         occurrences all number
    3
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 281 (0.71%)
    7 / 279 (2.51%)
         occurrences all number
    2
    8
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 281 (1.42%)
    2 / 279 (0.72%)
         occurrences all number
    4
    2
    Insomnia
         subjects affected / exposed
    4 / 281 (1.42%)
    0 / 279 (0.00%)
         occurrences all number
    5
    0
    Irritability
         subjects affected / exposed
    1 / 281 (0.36%)
    3 / 279 (1.08%)
         occurrences all number
    1
    3
    Libido decreased
         subjects affected / exposed
    3 / 281 (1.07%)
    3 / 279 (1.08%)
         occurrences all number
    3
    3
    Mood altered
         subjects affected / exposed
    3 / 281 (1.07%)
    1 / 279 (0.36%)
         occurrences all number
    3
    1
    Investigations
    Smear cervix abnormal
         subjects affected / exposed
    0 / 281 (0.00%)
    5 / 279 (1.79%)
         occurrences all number
    0
    5
    Weight decreased
         subjects affected / exposed
    3 / 281 (1.07%)
    3 / 279 (1.08%)
         occurrences all number
    3
    3
    Weight increased
         subjects affected / exposed
    8 / 281 (2.85%)
    10 / 279 (3.58%)
         occurrences all number
    8
    10
    Human papilloma virus test positive
         subjects affected / exposed
    3 / 281 (1.07%)
    5 / 279 (1.79%)
         occurrences all number
    3
    6
    Chlamydia test positive
         subjects affected / exposed
    2 / 281 (0.71%)
    4 / 279 (1.43%)
         occurrences all number
    2
    4
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    0 / 281 (0.00%)
    4 / 279 (1.43%)
         occurrences all number
    0
    5
    Contusion
         subjects affected / exposed
    3 / 281 (1.07%)
    0 / 279 (0.00%)
         occurrences all number
    3
    0
    Procedural pain
         subjects affected / exposed
    1 / 281 (0.36%)
    10 / 279 (3.58%)
         occurrences all number
    2
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    32 / 281 (11.39%)
    26 / 279 (9.32%)
         occurrences all number
    54
    93
    Migraine
         subjects affected / exposed
    5 / 281 (1.78%)
    2 / 279 (0.72%)
         occurrences all number
    11
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 281 (1.42%)
    21 / 279 (7.53%)
         occurrences all number
    5
    31
    Abdominal pain lower
         subjects affected / exposed
    5 / 281 (1.78%)
    12 / 279 (4.30%)
         occurrences all number
    5
    22
    Abdominal pain upper
         subjects affected / exposed
    6 / 281 (2.14%)
    3 / 279 (1.08%)
         occurrences all number
    6
    4
    Constipation
         subjects affected / exposed
    4 / 281 (1.42%)
    0 / 279 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    9 / 281 (3.20%)
    1 / 279 (0.36%)
         occurrences all number
    11
    2
    Gastritis
         subjects affected / exposed
    4 / 281 (1.42%)
    5 / 279 (1.79%)
         occurrences all number
    5
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 281 (1.07%)
    5 / 279 (1.79%)
         occurrences all number
    3
    5
    Nausea
         subjects affected / exposed
    14 / 281 (4.98%)
    9 / 279 (3.23%)
         occurrences all number
    16
    21
    Toothache
         subjects affected / exposed
    2 / 281 (0.71%)
    4 / 279 (1.43%)
         occurrences all number
    2
    5
    Vomiting
         subjects affected / exposed
    8 / 281 (2.85%)
    4 / 279 (1.43%)
         occurrences all number
    9
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 281 (2.14%)
    34 / 279 (12.19%)
         occurrences all number
    6
    41
    Rash
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Skin disorder
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 281 (0.71%)
    3 / 279 (1.08%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 281 (1.42%)
    8 / 279 (2.87%)
         occurrences all number
    6
    8
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    6 / 281 (2.14%)
    5 / 279 (1.79%)
         occurrences all number
    6
    5
    Bacterial vaginosis
         subjects affected / exposed
    3 / 281 (1.07%)
    18 / 279 (6.45%)
         occurrences all number
    3
    21
    Bronchitis
         subjects affected / exposed
    4 / 281 (1.42%)
    5 / 279 (1.79%)
         occurrences all number
    6
    5
    Cystitis
         subjects affected / exposed
    15 / 281 (5.34%)
    23 / 279 (8.24%)
         occurrences all number
    19
    31
    Ear infection
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Gastroenteritis
         subjects affected / exposed
    4 / 281 (1.42%)
    5 / 279 (1.79%)
         occurrences all number
    4
    5
    Gonorrhoea
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Influenza
         subjects affected / exposed
    3 / 281 (1.07%)
    5 / 279 (1.79%)
         occurrences all number
    3
    9
    Nasopharyngitis
         subjects affected / exposed
    13 / 281 (4.63%)
    22 / 279 (7.89%)
         occurrences all number
    17
    43
    Sinusitis
         subjects affected / exposed
    6 / 281 (2.14%)
    3 / 279 (1.08%)
         occurrences all number
    7
    3
    Tonsillitis
         subjects affected / exposed
    4 / 281 (1.42%)
    7 / 279 (2.51%)
         occurrences all number
    5
    7
    Urinary tract infection
         subjects affected / exposed
    4 / 281 (1.42%)
    14 / 279 (5.02%)
         occurrences all number
    4
    17
    Vaginal infection
         subjects affected / exposed
    7 / 281 (2.49%)
    11 / 279 (3.94%)
         occurrences all number
    8
    15
    Vaginitis gardnerella
         subjects affected / exposed
    1 / 281 (0.36%)
    4 / 279 (1.43%)
         occurrences all number
    1
    6
    Vulvitis
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Vulvovaginal candidiasis
         subjects affected / exposed
    6 / 281 (2.14%)
    15 / 279 (5.38%)
         occurrences all number
    7
    19
    Vulvovaginitis
         subjects affected / exposed
    3 / 281 (1.07%)
    4 / 279 (1.43%)
         occurrences all number
    5
    5
    Tooth infection
         subjects affected / exposed
    3 / 281 (1.07%)
    0 / 279 (0.00%)
         occurrences all number
    3
    0
    Chlamydial infection
         subjects affected / exposed
    1 / 281 (0.36%)
    3 / 279 (1.08%)
         occurrences all number
    1
    3
    Vulvovaginal mycotic infection
         subjects affected / exposed
    7 / 281 (2.49%)
    10 / 279 (3.58%)
         occurrences all number
    7
    13
    Vulvovaginitis streptococcal
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Vaginitis chlamydial
         subjects affected / exposed
    0 / 281 (0.00%)
    3 / 279 (1.08%)
         occurrences all number
    0
    3
    Candida infection
         subjects affected / exposed
    2 / 281 (0.71%)
    4 / 279 (1.43%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2011
    The extension phase for LCS12 users was added. Several of the original exclusion criteria were clarified under Amendment 1. An 18-month Extension Phase for subjects in the LCS12 treatment group was added. The timing of Visit 2 and switching of subjects from other forms of contraception was modified. Modified the protocol in response to requests from German Health Authority, to state that in Germany, only a gynaecologist may (1) insert the LCS12 and (2) perform gynaecologic investigations and procedures required by the study protocol. The section on withdrawal of subjects from the study was modified to state that subjects experiencing new-onset of migraine with neurological symptoms, thromboembolic diseases during study treatment, icterus or pronounced increase in blood pressured MUST be withdrawn from treatment. The size of ovarian cysts to be reported as AEs from 5 cm to >3 cm was changed. Discontinued collection of dysmenorrhea data in the subjects’ diaries.
    22 Jul 2011
    The primary endpoint was clarified. Instructions regarding the use of backup contraception by LCS12 subjects who prematurely discontinued the study were modified. Safety follow-up and EOS assessments for subjects who prematurely discontinued the study was clarified. Clarified protocol to ensure that all pregnancies occurring during the study were appropriately reported to the Sponsor, not only those occurring while study drug was being used. Modified the protocol to indicate that the final clinical study report was not to include the results for the assessment of return to fertility as these data would not be available at the time of database closure. Corrected inconsistent information in the protocol regarding the time allowed between the Screening Visit and Treatment-assignment Visit. Changed definition of a compliant cycle in the COC group to indicate that no tablet could be forgotten on Cycle Days 1 through 21 and that the cycle length was to be no more than 28 days.

    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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