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    Clinical Trial Results:
    A multicenter, double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of an oral contraceptive preparation YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) for 6 treatment cycles in women with moderate acne vulgaris

    Summary
    EudraCT number
    		 2014-004612-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 May 2010

    Results information
    Results version number
    		 v1
    This version publication date
    12 Jul 2016
    First version publication date
    05 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-5300/91772
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00818519
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other study ID: 311963
    Sponsors
    Sponsor organisation name
    Bayer HealthCare AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, D-51368, Leverkusen, Germany,
    Public contact
    Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.com
    Scientific contact
    Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.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
    18 May 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy and safety of YAZ (drospirenone 3 milligram [mg] / ethinylestradiol 20 microgram [mcg]) in comparison with placebo in Chinese female subjects with moderate acne vulgaris over 6 treatment 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. Before entering the study, the informed consent form was read by and explained to all subjects and/or their legally authorized representative. 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
    23 Dec 2008
    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
    China: 179
    Worldwide total number of subjects
    179
    EEA total number of subjects
    0
    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)
    6
    Adults (18-64 years)
    173
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Analyzed: 179 subjects randomized, 173 in the Full Analysis Set (FAS): 87 in YAZ, 86 in placebo groups, 143 in the Per Protocol Set (PPS): 74 in YAZ, 69 in placebo groups.

    Pre-assignment
    Screening details
    		 193 subjects screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), subject lost/no further information available (1). Study drug intake was unknown (3) and 3 subjects to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EE20/Drospirenone (YAZ, BAY86-5300)
    Arm description
    		 In the active treatment group, subjects received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg Drospirenone (DRSP) and 20 mcg Ethinyl estradiol (EE).
    Arm type
    		 Experimental

    Investigational medicinal product name
    EE20/Drospirenone (YAZ)
    Investigational medicinal product code
    BAY86-5300
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received active tablet containing 3 mg DRSP and 20 mcg EE. Subjects received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets.

    Arm title
    		 Placebo
    Arm description
    		 The subjects of the placebo group received inert but identical-appearing, color-matched tablets.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects of the placebo group received inert but identical-appearing, color-matched tablets.

    Number of subjects in period 1 [1]
    		EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Started
    87
    86
    Subjects received treatment
    87
    86
    Completed
    75
    71
    Not completed
    12
    15
         Consent withdrawn by subject
    2
    6
         Adverse Event
    2
    2
         Pregnancy
    -
    1
         Subject recovered completely
    1
    -
         Lost to follow-up
    4
    5
         Subject will leave for long time
    1
    -
         Protocol deviation
    2
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: All randomized subjects who took at least one tablet of study medication and who provided at least one observation after taking of the first tablet were included in the full analysis set and the baseline data was provided for those subjects. Hence, the worldwide number of subjects enrolled in the trial differs from the number of subjects with data reported for the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EE20/Drospirenone (YAZ, BAY86-5300)
    Reporting group description
    		 In the active treatment group, subjects received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg Drospirenone (DRSP) and 20 mcg Ethinyl estradiol (EE).

    Reporting group title
    Placebo
    Reporting group description
    		 The subjects of the placebo group received inert but identical-appearing, color-matched tablets.

    Reporting group values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo Total
    Number of subjects
    		 87 86
    Age categorical
    Units: Subjects
    Age continuous
    Age of subjects was derived from birth date entered onto Case Report Form (CRF).
    Units: years
        arithmetic mean (standard deviation)
    		 24 ( 5.8 ) 23.4 ( 5.4 ) -
    Gender categorical
    Gender categorical
    Units: subjects
        Female
    		 87 86 173

    End points

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    End points reporting groups
    Reporting group title
    EE20/Drospirenone (YAZ, BAY86-5300)
    Reporting group description
    		 In the active treatment group, subjects received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg Drospirenone (DRSP) and 20 mcg Ethinyl estradiol (EE).

    Reporting group title
    Placebo
    Reporting group description
    		 The subjects of the placebo group received inert but identical-appearing, color-matched tablets.

    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 took at least one tablet of study medication and who provided at least one observation after taking of the first tablet. Study drug intake was unknown (3) and 3 subjects to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.

    Subject analysis set title
    Per Protocol Analysis Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPS included all subjects in the FAS who met all the eligibility criteria, had no major protocol deviations which might affect the primary target variable, did not take any prohibited medication, had 80 percent (%) or higher overall study drug compliance, and completed a minimum of 5 treatment cycles.

    Primary: Percent Change from Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)

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    End point title
    		 Percent Change from Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set) [1]
    End point description
    Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, that is (i.e.), non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Primary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    87 [2]
    86 [3]
    Units: Percent change
        arithmetic mean (standard deviation)
    66.79 ( 31.45 )
    37.71 ( 118.73 )
    Notes
    [2] - FAS
    [3] - FAS
    No statistical analyses for this end point

    Primary: Percent Change from Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)

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    End point title
    		 Percent Change from Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set) [4]
    End point description
    Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Primary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    Notes
    [4] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    74 [5]
    69 [6]
    Units: Percent change
        arithmetic mean (standard deviation)
    72.63 ( 27.45 )
    55.56 ( 32.5 )
    Notes
    [5] - PPS
    [6] - PPS
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit

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    End point title
    		 Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit
    End point description
    ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear, few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions.
    End point type
    Secondary
    End point timeframe
    Screening visit
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    87 [7]
    86 [8]
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    Notes
    [7] - Full analysis set at screening
    [8] - Full analysis set at screening
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1

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    End point title
    		 Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1
    End point description
    ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear, few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (Day 15 +/- 3 days of Treatment Cycle 1)
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    84 [9]
    84 [10]
    Units: Percentage of subjects
        number (not applicable)
    1.2
    0
    Notes
    [9] - FAS, all subjects with data for Cycle 1.
    [10] - FAS, all subjects with data for Cycle 1.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3

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    End point title
    		 Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3
    End point description
    ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear, few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions.
    End point type
    Secondary
    End point timeframe
    Cycle 3 (Day 15 +/- 3 days of Treatment Cycle 3)
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    81 [11]
    81 [12]
    Units: Percentage of subjects
        number (not applicable)
    2.5
    4.9
    Notes
    [11] - FAS, all subjects with data for Cycle 3.
    [12] - FAS, all subjects with data for Cycle 3.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6

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    End point title
    		 Percentage of Subjects Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6
    End point description
    ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear, few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6)
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    73 [13]
    71 [14]
    Units: Percentage of subjects
        number (not applicable)
    49.3
    18.3
    Notes
    [13] - FAS, all subjects with data for Cycle 6.
    [14] - FAS, all subjects with data for Cycle 6.
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count
    End point description
    Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    75 [15]
    71 [16]
    Units: Percent change
    arithmetic mean (standard deviation)
        Inflammatory lesion count
    75.49 ( 28.11 )
    60.88 ( 29.92 )
        Non-inflammatory lesion count
    69.27 ( 33.75 )
    50.24 ( 49.93 )
    Notes
    [15] - FAS (due to missing data number of subjects differs from number at Baseline).
    [16] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Lesion Count of Papules

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Lesion Count of Papules
    End point description
    Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    75 [17]
    71 [18]
    Units: Percent change
        arithmetic mean (standard deviation)
    72.36 ( 31.32 )
    55.03 ( 40.19 )
    Notes
    [17] - FAS (due to missing data number of subjects differs from number at Baseline).
    [18] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Lesion Count of Pustules

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Lesion Count of Pustules
    End point description
    Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    64 [19]
    61 [20]
    Units: Percent change
        arithmetic mean (standard deviation)
    79.88 ( 40.83 )
    78.15 ( 34.37 )
    Notes
    [19] - FAS (due to missing data number of subjects differs from number at Baseline).
    [20] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Lesion Count of Nodules

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Lesion Count of Nodules
    End point description
    Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    32 [21]
    30 [22]
    Units: Percent change
        arithmetic mean (standard deviation)
    95.83 ( 18.45 )
    95 ( 20.13 )
    Notes
    [21] - FAS (due to missing data number of subjects differs from number at Baseline).
    [22] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Lesion Count of Open Comedones

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Lesion Count of Open Comedones
    End point description
    Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    72 [23]
    69 [24]
    Units: Percent change
        arithmetic mean (standard deviation)
    24.03 ( 289.46 )
    38.31 ( 94.52 )
    Notes
    [23] - FAS (due to missing data number of subjects differs from number at Baseline).
    [24] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percent Change from Cycle 6 to Baseline in Lesion Count of Closed comedones

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    End point title
    		 Percent Change from Cycle 6 to Baseline in Lesion Count of Closed comedones
    End point description
    Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.
    End point type
    Secondary
    End point timeframe
    Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6) and Baseline
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    75 [25]
    70 [26]
    Units: Percent change
        arithmetic mean (standard deviation)
    69.52 ( 42.24 )
    48.73 ( 61.16 )
    Notes
    [25] - FAS (due to missing data number of subjects differs from number at Baseline).
    [26] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Subject's Overall Self-Assessment Rating

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    End point title
    		 Percentage of Subjects Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Subject's Overall Self-Assessment Rating
    End point description
    The proportion of subjects rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Subject's Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise "not improved" status.
    End point type
    Secondary
    End point timeframe
    At Cycle 6 (Day 15 +/- 3 days of Treatment Cycle 6, 28 days per cycle)
    End point values
    		 EE20/Drospirenone (YAZ, BAY86-5300) Placebo
    Number of subjects analysed
    79 [27]
    73 [28]
    Units: Percentage of subjects
    number (not applicable)
        Investigator
    93.7
    78.1
        Subject
    94.9
    84.9
    Notes
    [27] - FAS (due to missing data number of subjects differs from number at Baseline).
    [28] - FAS (due to missing data number of subjects differs from number at Baseline).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of informed consent signed until last follow-up visit (15 days after the end of the Cycle 6-medication phase)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 The subjects of the placebo group received inert but identical-appearing, color-matched tablets.

    Reporting group title
    EE20/Drospirenone (YAZ, BAY86-5300)
    Reporting group description
    		 In the active treatment group, subjects received 24 consecutive days of active tablets followedby 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP and 20 mcg EE.

    Serious adverse events
    		 Placebo EE20/Drospirenone (YAZ, BAY86-5300)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 86 (0.00%)
    0 / 87 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo EE20/Drospirenone (YAZ, BAY86-5300)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 86 (34.88%)
    43 / 87 (49.43%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 86 (1.16%)
    3 / 87 (3.45%)
         occurrences all number
    1
    4
    Blood potassium decreased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 87 (2.30%)
         occurrences all number
    0
    2
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Red blood cells urine positive
         subjects affected / exposed
    4 / 86 (4.65%)
    1 / 87 (1.15%)
         occurrences all number
    7
    1
    White blood cells urine positive
         subjects affected / exposed
    2 / 86 (2.33%)
    2 / 87 (2.30%)
         occurrences all number
    3
    2
    White blood cell count decreased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 87 (2.30%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 87 (2.30%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences all number
    2
    1
    Breast mass
         subjects affected / exposed
    9 / 86 (10.47%)
    7 / 87 (8.05%)
         occurrences all number
    9
    7
    Cervical dysplasia
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 87 (0.00%)
         occurrences all number
    2
    0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Hypomenorrhoea
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Oligomenorrhoea
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Menorrhagia
         subjects affected / exposed
    0 / 86 (0.00%)
    9 / 87 (10.34%)
         occurrences all number
    0
    11
    Menstrual disorder
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 86 (0.00%)
    7 / 87 (8.05%)
         occurrences all number
    0
    10
    Menstruation delayed
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 87 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Cervicitis
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 87 (1.15%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 86 (2.33%)
    4 / 87 (4.60%)
         occurrences all number
    2
    4
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Papilloma viral infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 87 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 87 (1.15%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Decimal places were automatically truncated if last decimal equals zero.
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