Effects of SH T00658ID on Libido

Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00764881

Enrollment

217

Registered

2008-10-02

Start date

2009-01-31

Completion date

2010-07-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Libido

Keywords

Oral contraceptive, Sexual dysfunction, Libido

Brief summary

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Interventions

DRUGEV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose

DRUGMicrogynon

Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.

DRUGPlacebo

Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon * Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion criteria

* Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

Design outcomes

Primary

Measure	Time frame	Description
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)	Baseline up to Cycle 6 (28 days per Cycle)	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).
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)	Baseline up to Cycle 6 (28 days per Cycle)	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).

Secondary

Measure	Time frame	Description
The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	At Baseline	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	At Baseline	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).
The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	At Baseline	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).
The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	At Baseline	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).
The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	At Baseline	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).
The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of FSFI Total Score at Baseline	At Baseline	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
The Mean Absolute Values of FSFI Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).
Mean Change From Baseline to Cycle 6 in FSFI Total Score	Baseline up to Cycle 6 (28 days per Cycle)	The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	At Baseline	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).
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	At Baseline	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).
The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	At Baseline	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
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	At Cycle 6 (28 days per Cycle)	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
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	Baseline up to Cycle 6 (28 days per Cycle)	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).
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	At Baseline	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.
The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	Baseline up to Cycle 6 (28 days per Cycle)	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).
Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Vaginal Effects Evaluated by Vaginal pH at Cycle 6	At Cycle 6 (28 days per Cycle)	Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	At Baseline	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).
Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	Baseline up to Cycle 6 (28 days per Cycle)	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).
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	At Baseline	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).
Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	Baseline up to Cycle 6 (28 days per Cycle)	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).
Number of Bleeding / Spotting Days in Reference Period 1	From Day 1 to Day 90	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.
Number of Bleeding / Spotting Days in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to 180 during study treatment
Number of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	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
Number of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment
Mean Length of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	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
Mean Length of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	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.
Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	From Day 1 to Day 90	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.
Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Number of Spotting Only Days in Reference Period 1	From Day 1 to Day 90	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.
Number of Spotting Only Days in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Number of Spotting Only Episodes in Reference Period 1	From Day 1 to Day 90	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.
Number of Spotting Only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Mean Length of Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	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.
Mean Length of Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Maximum Length of Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	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.
Maximum Length of Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	From Day 1 to Day 90	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.
Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	From Day 91 to Day 180	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	At Cycle 1 (28 days per Cycle)	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
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	At Cycle 3 (28 days per Cycle)	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
Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	At Cycle 6 (28 days per Cycle)	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
Length of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	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
Length of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	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
Length of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	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
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	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.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	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.
Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Onset of Withdrawal Bleeding Episodes at Cycle 1	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1	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.
Onset of Withdrawal Bleeding Episodes at Cycle 3	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3	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.
Onset of Withdrawal Bleeding Episodes at Cycle 6	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6	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.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	At Cycle 6 (28 days per Cycle)	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).
Number of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	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.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	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.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Days at Cycle 1	At Cycle 1 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Days at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Days at Cycle 6	At Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	At Cycle 1 (28 days per Cycle)	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.
Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	Up to Cycle 6 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Number of Intracyclic Bleeding Episodes at Cycle 3	At Cycle 3 (28 days per Cycle)	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	At Baseline	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).

Countries

Australia, Austria, Belgium, Germany, Italy, Spain, Thailand

Participant flow

Recruitment details

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

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	106
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.	107
Total	213

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Accidentally discontinued study drug	1	0
Overall Study	Adverse Event	5	1
Overall Study	Carcinoma detected	1	0
Overall Study	Lost to Follow-up	2	0
Overall Study	Noncompliant	1	0
Overall Study	no treatment or no observation	2	2
Overall Study	Possibly noncompliant (study drug)	0	2
Overall Study	Protocol Violation	2	2
Overall Study	Wished to become pregnant	1	0
Overall Study	Withdrawal by Subject	1	3

Baseline characteristics

Characteristic	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo	Total
Age, Continuous	30.9 years STANDARD_DEVIATION 7	30.2 years STANDARD_DEVIATION 7.8	30.5 years STANDARD_DEVIATION 7.4
Body Mass Index (BMI)	22.8 kg/m^2 STANDARD_DEVIATION 3.2	22.7 kg/m^2 STANDARD_DEVIATION 2.9	22.8 kg/m^2 STANDARD_DEVIATION 3
Ethnic group Asian	16 participants	13 participants	29 participants
Ethnic group Caucasian	90 participants	92 participants	182 participants
Ethnic group Hispanic	0 participants	1 participants	1 participants
Ethnic group Other	0 participants	1 participants	1 participants
Sex: Female, Male Female	106 Participants	107 Participants	213 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	32 / 106	11 / 107
serious Total, serious adverse events	3 / 106	0 / 107

Outcome results

Primary

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)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	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)	5.98 scores on a scale	Standard Deviation 6.22

Primary

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)

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).

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	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)	6.37 scores on a scale	Standard Deviation 5.86

Secondary

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

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.

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	3.8 Days	Standard Deviation 4.5
EE/LNG (Microgynon) + Placebo	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	2.2 Days	Standard Deviation 2.7

Secondary

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	2.3 Days	Standard Deviation 2.4
EE/LNG (Microgynon) + Placebo	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	1.3 Days	Standard Deviation 1.5

Secondary

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	1.1 Days	Standard Deviation 1.6
EE/LNG (Microgynon) + Placebo	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	1.0 Days	Standard Deviation 1.9

Secondary

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	1.3 Days	Standard Deviation 2
EE/LNG (Microgynon) + Placebo	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	0.8 Days	Standard Deviation 1.7

Secondary

Length of Withdrawal Bleeding Episodes at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Length of Withdrawal Bleeding Episodes at Cycle 1	4.3 Days	Standard Deviation 2.4
EE/LNG (Microgynon) + Placebo	Length of Withdrawal Bleeding Episodes at Cycle 1	4.6 Days	Standard Deviation 1.9

Secondary

Length of Withdrawal Bleeding Episodes at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Length of Withdrawal Bleeding Episodes at Cycle 3	4.3 Days	Standard Deviation 2.6
EE/LNG (Microgynon) + Placebo	Length of Withdrawal Bleeding Episodes at Cycle 3	4.4 Days	Standard Deviation 1.5

Secondary

Length of Withdrawal Bleeding Episodes at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Length of Withdrawal Bleeding Episodes at Cycle 6	3.4 Days	Standard Deviation 1.4
EE/LNG (Microgynon) + Placebo	Length of Withdrawal Bleeding Episodes at Cycle 6	4.0 Days	Standard Deviation 1.3

Secondary

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	3.1 Scores on a scale	Standard Deviation 0.8
EE/LNG (Microgynon) + Placebo	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	3.7 Scores on a scale	Standard Deviation 0.8

Secondary

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	3.2 Scores on a scale	Standard Deviation 0.8
EE/LNG (Microgynon) + Placebo	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	3.8 Scores on a scale	Standard Deviation 0.7

Secondary

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	3.0 Scores on a scale	Standard Deviation 1
EE/LNG (Microgynon) + Placebo	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	3.6 Scores on a scale	Standard Deviation 0.9

Secondary

Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	6.6 Days	Standard Deviation 4.7
EE/LNG (Microgynon) + Placebo	Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	5.6 Days	Standard Deviation 2.6

Secondary

Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	5.3 Days	Standard Deviation 2.9
EE/LNG (Microgynon) + Placebo	Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	4.7 Days	Standard Deviation 1.6

Secondary

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	3.5 Days	Standard Deviation 3.4
EE/LNG (Microgynon) + Placebo	Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	2.4 Days	Standard Deviation 1.9

Secondary

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	5.0 Days	Standard Deviation 5.2
EE/LNG (Microgynon) + Placebo	Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	2.8 Days	Standard Deviation 2.4

Secondary

Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	3.5 Days	Standard Deviation 1.4
EE/LNG (Microgynon) + Placebo	Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	5.0 Days	Standard Deviation 5.7

Secondary

Maximum Length of Spotting-only Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Spotting-only Episodes in Reference Period 1	3.9 Days	Standard Deviation 3.5
EE/LNG (Microgynon) + Placebo	Maximum Length of Spotting-only Episodes in Reference Period 1	3.3 Days	Standard Deviation 2.4

Secondary

Maximum Length of Spotting-only Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Maximum Length of Spotting-only Episodes in Reference Period 2	3.9 Days	Standard Deviation 2.8
EE/LNG (Microgynon) + Placebo	Maximum Length of Spotting-only Episodes in Reference Period 2	3.7 Days	Standard Deviation 2.9

Secondary

Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	-9.6 Scores on a scale	Standard Deviation 10.5

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	1.43 scores on a scale	Standard Deviation 1.25
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	1.24 scores on a scale	Standard Deviation 1.53

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	1.02 scores on a scale	Standard Deviation 0.98
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	1.11 scores on a scale	Standard Deviation 1.02

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	1.36 Scores on a scale	Standard Deviation 1.53
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	1.04 Scores on a scale	Standard Deviation 1.91

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	1.26 Scores on a scale	Standard Deviation 1.52
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	1.06 Scores on a scale	Standard Deviation 1.65

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	0.69 Scores on a scale	Standard Deviation 1.83
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	0.22 Scores on a scale	Standard Deviation 1.89

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	1.03 Scores on a scale	Standard Deviation 1.24
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	1.03 Scores on a scale	Standard Deviation 1.2

Secondary

Mean Change From Baseline to Cycle 6 in FSFI Total Score

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

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Change From Baseline to Cycle 6 in FSFI Total Score	6.7 Scores on a scale	Standard Deviation 6.9
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in FSFI Total Score	5.7 Scores on a scale	Standard Deviation 7.8

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	2.6 Scores on a scale	Standard Deviation 15.4

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	4.25 Scores on a scale	Standard Deviation 11.38

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	-0.15 Scores on a scale	Standard Deviation 14.14

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	1.90 Scores on a scale	Standard Deviation 7.23

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	0.98 Scores on a scale	Standard Deviation 7.55

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	0.71 Scores on a scale	Standard Deviation 9.84

Secondary

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	2.65 Scores on a scale	Standard Deviation 10.07

Secondary

Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	4.12 Scores on a scale	Standard Deviation 10.71

Secondary

Mean Length of Bleeding / Spotting Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Length of Bleeding / Spotting Episodes in Reference Period 1	4.47 Days	Standard Deviation 2.44
EE/LNG (Microgynon) + Placebo	Mean Length of Bleeding / Spotting Episodes in Reference Period 1	4.42 Days	Standard Deviation 1.36

Secondary

Mean Length of Bleeding / Spotting Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Length of Bleeding / Spotting Episodes in Reference Period 2	4.13 Days	Standard Deviation 2.09
EE/LNG (Microgynon) + Placebo	Mean Length of Bleeding / Spotting Episodes in Reference Period 2	4.03 Days	Standard Deviation 1.17

Secondary

Mean Length of Spotting-only Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Length of Spotting-only Episodes in Reference Period 1	3.38 Days	Standard Deviation 3.43
EE/LNG (Microgynon) + Placebo	Mean Length of Spotting-only Episodes in Reference Period 1	2.79 Days	Standard Deviation 1.77

Secondary

Mean Length of Spotting-only Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Mean Length of Spotting-only Episodes in Reference Period 2	3.18 Days	Standard Deviation 2.26
EE/LNG (Microgynon) + Placebo	Mean Length of Spotting-only Episodes in Reference Period 2	3.23 Days	Standard Deviation 2.46

Secondary

Number of Bleeding / Spotting Days in Reference Period 1

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.

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Bleeding / Spotting Days in Reference Period 1	16.3 Days	Standard Deviation 10.1
EE/LNG (Microgynon) + Placebo	Number of Bleeding / Spotting Days in Reference Period 1	15.3 Days	Standard Deviation 5.6

Secondary

Number of Bleeding / Spotting Days in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Bleeding / Spotting Days in Reference Period 2	12.2 Days	Standard Deviation 8.2
EE/LNG (Microgynon) + Placebo	Number of Bleeding / Spotting Days in Reference Period 2	12.6 Days	Standard Deviation 5.4

Secondary

Number of Bleeding / Spotting Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Bleeding / Spotting Episodes in Reference Period 1	3.5 episodes	Standard Deviation 1.5
EE/LNG (Microgynon) + Placebo	Number of Bleeding / Spotting Episodes in Reference Period 1	3.3 episodes	Standard Deviation 1.3

Secondary

Number of Bleeding / Spotting Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Bleeding / Spotting Episodes in Reference Period 2	3.0 episodes	Standard Deviation 1.6
EE/LNG (Microgynon) + Placebo	Number of Bleeding / Spotting Episodes in Reference Period 2	3.1 episodes	Standard Deviation 0.7

Secondary

Number of Intracyclic Bleeding Days at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Days at Cycle 1	0.6 Days	Standard Deviation 1.9
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Days at Cycle 1	0.1 Days	Standard Deviation 0.8

Secondary

Number of Intracyclic Bleeding Days at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Days at Cycle 3	0.9 Days	Standard Deviation 2.9
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Days at Cycle 3	0.1 Days	Standard Deviation 0.7

Secondary

Number of Intracyclic Bleeding Days at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Days at Cycle 6	0.6 Days	Standard Deviation 1.4
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Days at Cycle 6	0.3 Days	Standard Deviation 1.6

Secondary

Number of Intracyclic Bleeding Episodes at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Episodes at Cycle 1	0.2 episodes	Standard Deviation 0.5
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Episodes at Cycle 1	0.1 episodes	Standard Deviation 0.3

Secondary

Number of Intracyclic Bleeding Episodes at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Episodes at Cycle 3	0.2 episodes	Standard Deviation 0.4
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Episodes at Cycle 3	0.1 episodes	Standard Deviation 0.3

Secondary

Number of Intracyclic Bleeding Episodes at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Intracyclic Bleeding Episodes at Cycle 6	0.2 episodes	Standard Deviation 0.4
EE/LNG (Microgynon) + Placebo	Number of Intracyclic Bleeding Episodes at Cycle 6	0.1 episodes	Standard Deviation 0.3

Secondary

Number of Spotting Only Days in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Spotting Only Days in Reference Period 1	7.6 Days	Standard Deviation 7.8
EE/LNG (Microgynon) + Placebo	Number of Spotting Only Days in Reference Period 1	3.8 Days	Standard Deviation 3.9

Secondary

Number of Spotting Only Days in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Spotting Only Days in Reference Period 2	6.1 Days	Standard Deviation 6
EE/LNG (Microgynon) + Placebo	Number of Spotting Only Days in Reference Period 2	3.3 Days	Standard Deviation 4.7

Secondary

Number of Spotting Only Episodes in Reference Period 1

Time frame: From Day 1 to Day 90

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Spotting Only Episodes in Reference Period 1	1.1 episodes	Standard Deviation 1.4
EE/LNG (Microgynon) + Placebo	Number of Spotting Only Episodes in Reference Period 1	0.4 episodes	Standard Deviation 1.1

Secondary

Number of Spotting Only Episodes in Reference Period 2

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

Time frame: From Day 91 to Day 180

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Number of Spotting Only Episodes in Reference Period 2	1.1 episodes	Standard Deviation 1.5
EE/LNG (Microgynon) + Placebo	Number of Spotting Only Episodes in Reference Period 2	0.4 episodes	Standard Deviation 1.1

Secondary

Onset of Withdrawal Bleeding Episodes at Cycle 1

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Onset of Withdrawal Bleeding Episodes at Cycle 1	3.5 Days	Standard Deviation 5
EE/LNG (Microgynon) + Placebo	Onset of Withdrawal Bleeding Episodes at Cycle 1	3.4 Days	Standard Deviation 2.3

Secondary

Onset of Withdrawal Bleeding Episodes at Cycle 3

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Onset of Withdrawal Bleeding Episodes at Cycle 3	4.2 Days	Standard Deviation 6.5
EE/LNG (Microgynon) + Placebo	Onset of Withdrawal Bleeding Episodes at Cycle 3	3.6 Days	Standard Deviation 2.6

Secondary

Onset of Withdrawal Bleeding Episodes at Cycle 6

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Onset of Withdrawal Bleeding Episodes at Cycle 6	1.1 Days	Standard Deviation 1.7
EE/LNG (Microgynon) + Placebo	Onset of Withdrawal Bleeding Episodes at Cycle 6	3.3 Days	Standard Deviation 1.1

Secondary

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

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.

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	spotting	75.0 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	light	6.3 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	normal	12.5 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	heavy	6.3 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	heavy	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	spotting	80.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	normal	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	light	20.0 Percentage of participants

Secondary

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

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.

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	spotting	64.7 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	light	23.5 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	heavy	0.0 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	normal	11.8 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	heavy	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	spotting	75.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	light	25.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	normal	0.0 Percentage of participants

Secondary

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	spotting	66.7 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	light	8.3 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	normal	16.7 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	heavy	8.3 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	heavy	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	spotting	100.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	normal	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	light	0.0 Percentage of participants

Secondary

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

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.

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	spotting	22.4 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	light	44.7 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	normal	30.3 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	heavy	2.6 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	heavy	13.5 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	spotting	7.7 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	normal	53.8 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	light	25.0 Percentage of participants

Secondary

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	spotting	26.5 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	light	33.7 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	normal	37.3 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	heavy	2.4 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	heavy	9.1 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	spotting	4.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	normal	61.6 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	light	25.3 Percentage of participants

Secondary

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	spotting	38.9 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	light	27.8 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	normal	27.8 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	heavy	5.6 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	heavy	13.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	spotting	13.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	normal	47.8 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	light	26.1 Percentage of participants

Secondary

Percentage of Participants With at Least 1 Intracyclic Bleeding Episode

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

Time frame: Up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	no	63.1 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	yes	36.9 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	no	87.9 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	yes	12.1 Percentage of participants

Secondary

Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	70.3 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	62.7 Percentage of participants

Secondary

Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	68.1 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	70.5 Percentage of participants

Secondary

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	with absence of intracyclic bleeding	84.2 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	with presence of intracyclic bleeding	15.8 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	with absence of intracyclic bleeding	95.3 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	with presence of intracyclic bleeding	4.7 Percentage of participants

Secondary

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	with absence of intracyclic bleeding	82.3 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	with presence of intracyclic bleeding	17.7 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	with absence of intracyclic bleeding	96.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	with presence of intracyclic bleeding	4.0 Percentage of participants

Secondary

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	with absence of intracyclic bleeding	83.8 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	with presence of intracyclic bleeding	16.2 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	with absence of intracyclic bleeding	94.7 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	with presence of intracyclic bleeding	5.3 Percentage of participants

Secondary

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1

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

Time frame: At Cycle 1 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	without withdrawal bleeding	24.8 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	with withdrawal bleeding	75.2 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	without withdrawal bleeding	2.8 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	with withdrawal bleeding	97.2 Percentage of participants

Secondary

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3

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

Time frame: At Cycle 3 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	without withdrawal bleeding	13.5 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	with withdrawal bleeding	86.5 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	without withdrawal bleeding	0.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	with withdrawal bleeding	100.0 Percentage of participants

Secondary

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	without withdrawal bleeding	51.4 Percentage of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	with withdrawal bleeding	48.6 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	without withdrawal bleeding	8.0 Percentage of participants
EE/LNG (Microgynon) + Placebo	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	with withdrawal bleeding	92.0 Percentage of participants

Secondary

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	27.5 Scores on a scale	Standard Deviation 10.2

Secondary

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	17.6 Scores on a scale	Standard Deviation 11.4

Secondary

The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	2.65 scores on a scale	Standard Deviation 0.94
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	2.77 scores on a scale	Standard Deviation 0.83

Secondary

The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	4.03 scores on a scale	Standard Deviation 1.23
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	4.05 scores on a scale	Standard Deviation 1.35

Secondary

The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	2.51 scores on a scale	Standard Deviation 0.72
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	2.39 scores on a scale	Standard Deviation 0.74

Secondary

The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	3.53 scores on a scale	Standard Deviation 0.95
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	3.52 scores on a scale	Standard Deviation 0.89

Secondary

The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	3.56 Scores on a scale	Standard Deviation 1.44
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	3.73 Scores on a scale	Standard Deviation 1.14

Secondary

The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	4.90 scores on a scale	Standard Deviation 1.18
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	4.81 scores on a scale	Standard Deviation 1.46

Secondary

The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	2.97 Scores on a scale	Standard Deviation 1.41
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	2.93 Scores on a scale	Standard Deviation 1.24

Secondary

The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	4.22 Scores on a scale	Standard Deviation 1.52
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	4.05 Scores on a scale	Standard Deviation 1.49

Secondary

The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	4.34 Scores on a scale	Standard Deviation 1.78
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	4.74 Scores on a scale	Standard Deviation 1.52

Secondary

The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	5.04 Scores on a scale	Standard Deviation 1.53
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	5.01 Scores on a scale	Standard Deviation 1.55

Secondary

The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	3.16 Scores on a scale	Standard Deviation 1.06
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	3.20 Scores on a scale	Standard Deviation 0.78

Secondary

The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	4.19 Scores on a scale	Standard Deviation 1.13
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	4.26 Scores on a scale	Standard Deviation 1.1

Secondary

The Mean Absolute Values of FSFI Total Score at Baseline

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

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Total Score at Baseline	19.2 scores on a scale	Standard Deviation 5.6
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Total Score at Baseline	19.8 scores on a scale	Standard Deviation 4.8

Secondary

The Mean Absolute Values of FSFI Total Score at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of FSFI Total Score at Cycle 6	25.8 Scores on a scale	Standard Deviation 6.5
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of FSFI Total Score at Cycle 6	25.7 Scores on a scale	Standard Deviation 6.8

Secondary

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	68.47 Scores on a scale	Standard Deviation 11.98

Secondary

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	72.48 Scores on a scale	Standard Deviation 10.57

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	70.3 Scores on a scale	Standard Deviation 15.7
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	71.5 Scores on a scale	Standard Deviation 16.1

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	74.8 Scores on a scale	Standard Deviation 16
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	74.1 Scores on a scale	Standard Deviation 15.6

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	85.79 Scores on a scale	Standard Deviation 12.16

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	89.94 Scores on a scale	Standard Deviation 9.61

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	81.00 Scores on a scale	Standard Deviation 13.74

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	81.17 Scores on a scale	Standard Deviation 13.31

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline

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

Time frame: At Baseline

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	67.98 Scores on a scale	Standard Deviation 7.36

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	69.86 Scores on a scale	Standard Deviation 6.95

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	48.46 Scores on a scale	Standard Deviation 6.53

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	49.26 Scores on a scale	Standard Deviation 6.23

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	66.66 Scores on a scale	Standard Deviation 8.36

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	67.18 Scores on a scale	Standard Deviation 8.33

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline

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.

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	60.27 Scores on a scale	Standard Deviation 10.81
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	60.93 Scores on a scale	Standard Deviation 9.01

Secondary

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6

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.

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	63.58 Scores on a scale	Standard Deviation 8.31

Secondary

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline

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).

Time frame: At Baseline

Population: FAS

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	0.47 Scores on a scale	Standard Deviation 0.48

Secondary

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6

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).

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	0.27 Scores on a scale	Standard Deviation 0.4
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	0.25 Scores on a scale	Standard Deviation 0.36

Secondary

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline

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).

Time frame: At Baseline

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	0.38 Scores on a scale	Standard Deviation 0.26

Secondary

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	0.31 Scores on a scale	Standard Deviation 0.12

Secondary

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)

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).

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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 0.5
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	-0.18 Scores on a scale	Standard Deviation 0.38

Secondary

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)

Time frame: Baseline up to Cycle 6 (28 days per Cycle)

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

Arm	Measure	Value (MEAN)	Dispersion
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	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
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	-0.06 Scores on a scale	Standard Deviation 0.27

Secondary

Vaginal Effects Evaluated by Vaginal pH at Cycle 6

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

Time frame: At Cycle 6 (28 days per Cycle)

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

Arm	Measure	Group	Value (NUMBER)
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH < 4.0	0.053 Proportion of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH 4.0 - 4.4	0.298 Proportion of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH 4.5 - 5.0	0.521 Proportion of participants
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH > 5.0	0.117 Proportion of participants
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH > 5.0	0.029 Proportion of participants
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH < 4.0	0.039 Proportion of participants
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH 4.5 - 5.0	0.637 Proportion of participants
EE/LNG (Microgynon) + Placebo	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH 4.0 - 4.4	0.294 Proportion of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Effects of SH T00658ID on Libido

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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)

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)

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

Length of Withdrawal Bleeding Episodes at Cycle 1

Length of Withdrawal Bleeding Episodes at Cycle 3

Length of Withdrawal Bleeding Episodes at Cycle 6

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

Maximum Length of Spotting-only Episodes in Reference Period 1

Maximum Length of Spotting-only Episodes in Reference Period 2

Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)

Mean Change From Baseline to Cycle 6 in FSFI Total Score

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality

Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score

Mean Length of Bleeding / Spotting Episodes in Reference Period 1

Mean Length of Bleeding / Spotting Episodes in Reference Period 2

Mean Length of Spotting-only Episodes in Reference Period 1

Mean Length of Spotting-only Episodes in Reference Period 2

Number of Bleeding / Spotting Days in Reference Period 1

Number of Bleeding / Spotting Days in Reference Period 2

Number of Bleeding / Spotting Episodes in Reference Period 1

Number of Bleeding / Spotting Episodes in Reference Period 2

Number of Intracyclic Bleeding Days at Cycle 1

Number of Intracyclic Bleeding Days at Cycle 3

Number of Intracyclic Bleeding Days at Cycle 6

Number of Intracyclic Bleeding Episodes at Cycle 1

Number of Intracyclic Bleeding Episodes at Cycle 3

Number of Intracyclic Bleeding Episodes at Cycle 6

Number of Spotting Only Days in Reference Period 1

Number of Spotting Only Days in Reference Period 2

Number of Spotting Only Episodes in Reference Period 1

Number of Spotting Only Episodes in Reference Period 2

Onset of Withdrawal Bleeding Episodes at Cycle 1

Onset of Withdrawal Bleeding Episodes at Cycle 3

Onset of Withdrawal Bleeding Episodes at Cycle 6

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1