Trial Outcomes & Findings for Effects of SH T00658ID on Libido (NCT NCT00764881)

Results Overview

Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

217 participants

Primary outcome timeframe

Baseline up to Cycle 6 (28 days per Cycle)

Results posted on

2014-12-30

Participant Flow

The date of first subject was 29 Jan 2009. The date of last subject was 20 Jul 2010.

Of 276 participants screened, 29 failed Screening, and 217 were randomized 1:1, of which 1 never received treatment, 3 had no observations, and 213 were treated (EV/DNG=106; EE/LNG=107).

Participant milestones

Participant milestones
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Overall Study STARTED	108	109
Overall Study Subjects Received Treatment	106	107
Overall Study COMPLETED	92	99
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Reasons for withdrawal
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Overall Study Adverse Event	5	1
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	2	2
Overall Study Lost to Follow-up	2	0
Overall Study Noncompliant	1	0
Overall Study Accidentally discontinued study drug	1	0
Overall Study Wished to become pregnant	1	0
Overall Study Carcinoma detected	1	0
Overall Study Possibly noncompliant (study drug)	0	2
Overall Study no treatment or no observation	2	2

Baseline Characteristics

Effects of SH T00658ID on Libido

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.	Total n=213 Participants Total of all reporting groups
Age, Continuous	30.9 years STANDARD_DEVIATION 7.0 • n=5 Participants	30.2 years STANDARD_DEVIATION 7.8 • n=7 Participants	30.5 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	107 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnic group Caucasian	90 participants n=5 Participants	92 participants n=7 Participants	182 participants n=5 Participants
Ethnic group Hispanic	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Ethnic group Asian	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Ethnic group Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Body Mass Index (BMI)	22.8 kg/m^2 STANDARD_DEVIATION 3.2 • n=5 Participants	22.7 kg/m^2 STANDARD_DEVIATION 2.9 • n=7 Participants	22.8 kg/m^2 STANDARD_DEVIATION 3.0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)	6.45 scores on a scale Standard Deviation 5.33	5.98 scores on a scale Standard Deviation 6.22

PRIMARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables

Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=92 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=95 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)	6.43 scores on a scale Standard Deviation 5.36	6.37 scores on a scale Standard Deviation 5.86

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	2.51 scores on a scale Standard Deviation 0.72	2.39 scores on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	3.53 scores on a scale Standard Deviation 0.95	3.52 scores on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	1.02 scores on a scale Standard Deviation 0.98	1.11 scores on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	2.65 scores on a scale Standard Deviation 0.94	2.77 scores on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	4.03 scores on a scale Standard Deviation 1.23	4.05 scores on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	1.43 scores on a scale Standard Deviation 1.25	1.24 scores on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	3.56 Scores on a scale Standard Deviation 1.44	3.73 Scores on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	4.90 scores on a scale Standard Deviation 1.18	4.81 scores on a scale Standard Deviation 1.46

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	1.36 Scores on a scale Standard Deviation 1.53	1.04 Scores on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	2.97 Scores on a scale Standard Deviation 1.41	2.93 Scores on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	4.22 Scores on a scale Standard Deviation 1.52	4.05 Scores on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	1.26 Scores on a scale Standard Deviation 1.52	1.06 Scores on a scale Standard Deviation 1.65

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	3.16 Scores on a scale Standard Deviation 1.06	3.20 Scores on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	4.19 Scores on a scale Standard Deviation 1.13	4.26 Scores on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	1.03 Scores on a scale Standard Deviation 1.24	1.03 Scores on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	4.34 Scores on a scale Standard Deviation 1.78	4.74 Scores on a scale Standard Deviation 1.52

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	5.04 Scores on a scale Standard Deviation 1.53	5.01 Scores on a scale Standard Deviation 1.55

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	0.69 Scores on a scale Standard Deviation 1.83	0.22 Scores on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Total Score at Baseline	19.2 scores on a scale Standard Deviation 5.6	19.8 scores on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of FSFI Total Score at Cycle 6	25.8 Scores on a scale Standard Deviation 6.5	25.7 Scores on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in FSFI Total Score	6.7 Scores on a scale Standard Deviation 6.9	5.7 Scores on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	25.6 Scores on a scale Standard Deviation 10.6	27.5 Scores on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	14.8 Scores on a scale Standard Deviation 10.2	17.6 Scores on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	-10.0 Scores on a scale Standard Deviation 10.4	-9.6 Scores on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	69.76 Scores on a scale Standard Deviation 10.85	68.47 Scores on a scale Standard Deviation 11.98

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	71.63 Scores on a scale Standard Deviation 11.72	72.48 Scores on a scale Standard Deviation 10.57

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	2.60 Scores on a scale Standard Deviation 11.26	4.12 Scores on a scale Standard Deviation 10.71

SECONDARY outcome

Timeframe: At Baseline

Population: All participants in FAS with assessment for this outcome measure

The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=105 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	67.75 Scores on a scale Standard Deviation 6.78	67.98 Scores on a scale Standard Deviation 7.36

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	69.20 Scores on a scale Standard Deviation 8.32	69.86 Scores on a scale Standard Deviation 6.95

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	1.93 Scores on a scale Standard Deviation 8.11	1.90 Scores on a scale Standard Deviation 7.23

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	70.3 Scores on a scale Standard Deviation 15.7	71.5 Scores on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	74.8 Scores on a scale Standard Deviation 16.0	74.1 Scores on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	4.9 Scores on a scale Standard Deviation 14.9	2.6 Scores on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	86.20 Scores on a scale Standard Deviation 11.38	85.79 Scores on a scale Standard Deviation 12.16

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	87.24 Scores on a scale Standard Deviation 13.15	89.94 Scores on a scale Standard Deviation 9.61

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	1.75 Scores on a scale Standard Deviation 13.17	4.25 Scores on a scale Standard Deviation 11.38

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	47.88 Scores on a scale Standard Deviation 9.05	48.46 Scores on a scale Standard Deviation 6.53

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	49.41 Scores on a scale Standard Deviation 6.63	49.26 Scores on a scale Standard Deviation 6.23

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	0.91 Scores on a scale Standard Deviation 9.81	0.98 Scores on a scale Standard Deviation 7.55

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	66.40 Scores on a scale Standard Deviation 9.35	66.66 Scores on a scale Standard Deviation 8.36

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	66.95 Scores on a scale Standard Deviation 9.53	67.18 Scores on a scale Standard Deviation 8.33

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	0.02 Scores on a scale Standard Deviation 12.21	0.71 Scores on a scale Standard Deviation 9.84

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	79.12 Scores on a scale Standard Deviation 14.75	81.00 Scores on a scale Standard Deviation 13.74

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	80.22 Scores on a scale Standard Deviation 13.95	81.17 Scores on a scale Standard Deviation 13.31

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	0.93 Scores on a scale Standard Deviation 15.57	-0.15 Scores on a scale Standard Deviation 14.14

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	60.27 Scores on a scale Standard Deviation 10.81	60.93 Scores on a scale Standard Deviation 9.01

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	61.83 Scores on a scale Standard Deviation 9.46	63.58 Scores on a scale Standard Deviation 8.31

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	1.42 Scores on a scale Standard Deviation 10.11	2.65 Scores on a scale Standard Deviation 10.07

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	68.1 Percentage of participants	70.5 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	70.3 Percentage of participants	62.7 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by Vaginal pH at Cycle 6 Vaginal pH < 4.0	0.053 Proportion of participants	0.039 Proportion of participants
Vaginal Effects Evaluated by Vaginal pH at Cycle 6 Vaginal pH 4.0 - 4.4	0.298 Proportion of participants	0.294 Proportion of participants
Vaginal Effects Evaluated by Vaginal pH at Cycle 6 Vaginal pH 4.5 - 5.0	0.521 Proportion of participants	0.637 Proportion of participants
Vaginal Effects Evaluated by Vaginal pH at Cycle 6 Vaginal pH > 5.0	0.117 Proportion of participants	0.029 Proportion of participants

SECONDARY outcome

Timeframe: At Baseline

Population: FAS

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	0.54 Scores on a scale Standard Deviation 0.55	0.47 Scores on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	0.27 Scores on a scale Standard Deviation 0.40	0.25 Scores on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	-0.27 Scores on a scale Standard Deviation 0.50	-0.18 Scores on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: At Baseline

Population: All participants in FAS with assessment for this outcome measure.

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=105 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	0.33 Scores on a scale Standard Deviation 0.14	0.38 Scores on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=93 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	0.34 Scores on a scale Standard Deviation 0.15	0.31 Scores on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH\<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=92 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=102 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	0.01 Scores on a scale Standard Deviation 0.18	-0.06 Scores on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Bleeding / Spotting Days in Reference Period 1	16.3 Days Standard Deviation 10.1	15.3 Days Standard Deviation 5.6

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to 180 during study treatment

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=68 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Bleeding / Spotting Days in Reference Period 2	12.2 Days Standard Deviation 8.2	12.6 Days Standard Deviation 5.4

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Bleeding / Spotting Episodes in Reference Period 1	3.5 episodes Standard Deviation 1.5	3.3 episodes Standard Deviation 1.3

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=68 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Bleeding / Spotting Episodes in Reference Period 2	3.0 episodes Standard Deviation 1.6	3.1 episodes Standard Deviation 0.7

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=90 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Length of Bleeding / Spotting Episodes in Reference Period 1	4.47 Days Standard Deviation 2.44	4.42 Days Standard Deviation 1.36

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=61 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Length of Bleeding / Spotting Episodes in Reference Period 2	4.13 Days Standard Deviation 2.09	4.03 Days Standard Deviation 1.17

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=90 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	6.6 Days Standard Deviation 4.7	5.6 Days Standard Deviation 2.6

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=61 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	5.3 Days Standard Deviation 2.9	4.7 Days Standard Deviation 1.6

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=90 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	3.8 Days Standard Deviation 4.5	2.2 Days Standard Deviation 2.7

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=61 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	2.3 Days Standard Deviation 2.4	1.3 Days Standard Deviation 1.5

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Spotting Only Days in Reference Period 1	7.6 Days Standard Deviation 7.8	3.8 Days Standard Deviation 3.9

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=68 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Spotting Only Days in Reference Period 2	6.1 Days Standard Deviation 6.0	3.3 Days Standard Deviation 4.7

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=94 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Spotting Only Episodes in Reference Period 1	1.1 episodes Standard Deviation 1.4	0.4 episodes Standard Deviation 1.1

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=68 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Spotting Only Episodes in Reference Period 2	1.1 episodes Standard Deviation 1.5	0.4 episodes Standard Deviation 1.1

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=50 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=22 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Length of Spotting-only Episodes in Reference Period 1	3.38 Days Standard Deviation 3.43	2.79 Days Standard Deviation 1.77

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=33 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=16 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Mean Length of Spotting-only Episodes in Reference Period 2	3.18 Days Standard Deviation 2.26	3.23 Days Standard Deviation 2.46

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=50 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=22 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Spotting-only Episodes in Reference Period 1	3.9 Days Standard Deviation 3.5	3.3 Days Standard Deviation 2.4

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=33 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=16 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Spotting-only Episodes in Reference Period 2	3.9 Days Standard Deviation 2.8	3.7 Days Standard Deviation 2.9

SECONDARY outcome

Timeframe: From Day 1 to Day 90

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=50 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=22 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	1.1 Days Standard Deviation 1.6	1.0 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: From Day 91 to Day 180

Population: All participants in FAS with assessment for this outcome measure.

Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=33 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=16 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	1.3 Days Standard Deviation 2.0	0.8 Days Standard Deviation 1.7

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=101 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 without withdrawal bleeding	24.8 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 with withdrawal bleeding	75.2 Percentage of participants	97.2 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=96 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 without withdrawal bleeding	13.5 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 with withdrawal bleeding	86.5 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=74 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 without withdrawal bleeding	51.4 Percentage of participants	8.0 Percentage of participants
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 with withdrawal bleeding	48.6 Percentage of participants	92.0 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=76 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=104 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Length of Withdrawal Bleeding Episodes at Cycle 1	4.3 Days Standard Deviation 2.4	4.6 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=83 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Length of Withdrawal Bleeding Episodes at Cycle 3	4.3 Days Standard Deviation 2.6	4.4 Days Standard Deviation 1.5

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=36 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=69 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Length of Withdrawal Bleeding Episodes at Cycle 6	3.4 Days Standard Deviation 1.4	4.0 Days Standard Deviation 1.3

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=76 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=104 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	3.1 Scores on a scale Standard Deviation 0.8	3.7 Scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=83 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	3.2 Scores on a scale Standard Deviation 0.8	3.8 Scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=36 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=69 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	3.0 Scores on a scale Standard Deviation 1.0	3.6 Scores on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=76 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=104 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 spotting	22.4 Percentage of participants	7.7 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 light	44.7 Percentage of participants	25.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 normal	30.3 Percentage of participants	53.8 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 heavy	2.6 Percentage of participants	13.5 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=83 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 spotting	26.5 Percentage of participants	4.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 light	33.7 Percentage of participants	25.3 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 normal	37.3 Percentage of participants	61.6 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 heavy	2.4 Percentage of participants	9.1 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=36 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=69 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 spotting	38.9 Percentage of participants	13.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 light	27.8 Percentage of participants	26.1 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 normal	27.8 Percentage of participants	47.8 Percentage of participants
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 heavy	5.6 Percentage of participants	13.0 Percentage of participants

SECONDARY outcome

Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1

Population: All participants in FAS with assessment for this outcome measure.

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=76 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=104 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Onset of Withdrawal Bleeding Episodes at Cycle 1	3.5 Days Standard Deviation 5.0	3.4 Days Standard Deviation 2.3

SECONDARY outcome

Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3

Population: All participants in FAS with assessment for this outcome measure.

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=83 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Onset of Withdrawal Bleeding Episodes at Cycle 3	4.2 Days Standard Deviation 6.5	3.6 Days Standard Deviation 2.6

SECONDARY outcome

Timeframe: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6

Population: All participants in FAS with assessment for this outcome measure.

Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=36 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=69 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Onset of Withdrawal Bleeding Episodes at Cycle 6	1.1 Days Standard Deviation 1.7	3.3 Days Standard Deviation 1.1

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=101 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 with absence of intracyclic bleeding	84.2 Percentage of participants	95.3 Percentage of participants
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 with presence of intracyclic bleeding	15.8 Percentage of participants	4.7 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=96 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 with absence of intracyclic bleeding	82.3 Percentage of participants	96.0 Percentage of participants
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 with presence of intracyclic bleeding	17.7 Percentage of participants	4.0 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=74 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 with absence of intracyclic bleeding	83.8 Percentage of participants	94.7 Percentage of participants
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 with presence of intracyclic bleeding	16.2 Percentage of participants	5.3 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=101 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Episodes at Cycle 1	0.2 episodes Standard Deviation 0.5	0.1 episodes Standard Deviation 0.3

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=96 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Episodes at Cycle 3	0.2 episodes Standard Deviation 0.4	0.1 episodes Standard Deviation 0.3

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=74 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Episodes at Cycle 6	0.2 episodes Standard Deviation 0.4	0.1 episodes Standard Deviation 0.3

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=16 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=5 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	3.5 Days Standard Deviation 3.4	2.4 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=17 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=4 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	5.0 Days Standard Deviation 5.2	2.8 Days Standard Deviation 2.4

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=12 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=4 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	3.5 Days Standard Deviation 1.4	5.0 Days Standard Deviation 5.7

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=101 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Days at Cycle 1	0.6 Days Standard Deviation 1.9	0.1 Days Standard Deviation 0.8

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=96 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=99 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Days at Cycle 3	0.9 Days Standard Deviation 2.9	0.1 Days Standard Deviation 0.7

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=74 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=75 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Number of Intracyclic Bleeding Days at Cycle 6	0.6 Days Standard Deviation 1.4	0.3 Days Standard Deviation 1.6

SECONDARY outcome

Timeframe: At Cycle 1 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=16 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=5 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 spotting	75.0 Percentage of participants	80.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 light	6.3 Percentage of participants	20.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 normal	12.5 Percentage of participants	0.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 heavy	6.3 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 3 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=17 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=4 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 spotting	64.7 Percentage of participants	75.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 light	23.5 Percentage of participants	25.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 normal	11.8 Percentage of participants	0.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 heavy	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: At Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=12 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=4 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 spotting	66.7 Percentage of participants	100.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 light	8.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 normal	16.7 Percentage of participants	0.0 Percentage of participants
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 heavy	8.3 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Cycle 6 (28 days per Cycle)

Population: All participants in FAS with assessment for this outcome measure.

Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Outcome measures

Outcome measures
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=103 Participants Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.	EE/LNG (Microgynon) + Placebo n=107 Participants Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode no	63.1 Percentage of participants	87.9 Percentage of participants
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode yes	36.9 Percentage of participants	12.1 Percentage of participants

Adverse Events

EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

EE/LNG (Microgynon) + Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 participants at risk Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles	EE/LNG (Microgynon) + Placebo n=107 participants at risk Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
Infections and infestations Appendicitis	0.94% 1/106 • Number of events 1	0.00% 0/107
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.94% 1/106 • Number of events 1	0.00% 0/107
Vascular disorders Deep vein thrombosis	0.94% 1/106 • Number of events 1	0.00% 0/107

Other adverse events

Other adverse events
Measure	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) n=106 participants at risk Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles	EE/LNG (Microgynon) + Placebo n=107 participants at risk Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
Infections and infestations Bronchitis	2.8% 3/106 • Number of events 3	0.93% 1/107 • Number of events 1
Infections and infestations Influenza	4.7% 5/106 • Number of events 5	1.9% 2/107 • Number of events 2
Infections and infestations Pharyngitis	3.8% 4/106 • Number of events 4	0.93% 1/107 • Number of events 1
Infections and infestations Upper respiratory tract infection	3.8% 4/106 • Number of events 5	1.9% 2/107 • Number of events 2
Injury, poisoning and procedural complications Foot fracture	2.8% 3/106 • Number of events 3	0.00% 0/107
Musculoskeletal and connective tissue disorders Back pain	2.8% 3/106 • Number of events 3	0.93% 1/107 • Number of events 1
Nervous system disorders Headache	8.5% 9/106 • Number of events 31	4.7% 5/107 • Number of events 10
Nervous system disorders Migraine	2.8% 3/106 • Number of events 3	0.00% 0/107
Skin and subcutaneous tissue disorders Acne	2.8% 3/106 • Number of events 3	0.93% 1/107 • Number of events 1

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

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