Effects of SH T00658ID on Libido

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00764881
• Collaborator: (none)
• Enrollment: 217
• Locations: 32
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Libido	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Drug: Microgynon; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: EV/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
Active Comparator: 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.	Drug: Microgynon; 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.; Drug: Placebo; Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

7. 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).

8. 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).

9. 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).

10. 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).

11. 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).

12. 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).

13. 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).

14. 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).

15. 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).

16. 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).

17. 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).

18. 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).

19. 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).

20. 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).

21. 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).

22. 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).

23. 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).

24. 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).

25. 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).

26. 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).

27. 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).

28. 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

29. 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

30. 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).

31. 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.

32. 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.

33. 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).

34. 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.

35. 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.

36. 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).

37. 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.

38. 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.

39. 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).

40. 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.

41. 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.

42. 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).

43. 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.

44. 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.

45. 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).

46. 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.

47. 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.

48. 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).

49. 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.

50. 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.

51. 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

52. 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).

53. 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).

54. 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).

55. 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).

56. 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).

57. 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).

58. 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.

59. 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

60. 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

61. 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

62. 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

63. 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.

64. 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.

65. 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.

66. 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.

67. 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.

68. 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.

69. 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.

70. 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.

71. 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.

72. 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.

73. 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.

74. 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.

75. 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.

76. 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.

77. 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.

78. 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

79. 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

80. 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

81. 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

82. 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

83. 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

84. 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.

85. 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.

86. 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.

87. 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.

88. 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.

89. 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.

90. 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.

91. 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.

92. 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.

93. 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.

94. 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.

95. 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.

96. 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.

97. 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.

98. 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.

99. 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.

100. 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.

101. 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.

102. 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.

103. 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.

104. 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.

105. 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.

106. 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.

107. 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.

108. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sydney Centre for Reproductive Health Reseach	Ashfield	New South Wales	Australia	2031
2	Royal Hospital for Women	Sydney	New South Wales	Australia	2031
3	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
4	The Alfred Hospital	Prahran	Victoria	Australia	3121
5	Queen Elizabeth II Medical Centre	Nedlands	Western Australia	Australia	6009
6	King Edward Memorial Hospital	Subiaco	Western Australia	Australia	6008
7	Ordination Dr. Schmidl-Amann	St. Pölten	Niederösterreich	Austria	3100
8	Ordination Dr.Hohlweg	Graz	Steiermark	Austria	8010
9	Ordination Dr. Schaffer	Graz	Steiermark	Austria	8044
10	Dr. Brigitte Wiesenthal	Wien		Austria	1070
11	Clin Pharm International GmbH Studienzentrum Wien	Wien		Austria	1090
12	Dr. Wolfgang Bartl	Wien		Austria	1200
13	Dr. Walter Paulik	Zeltweg		Austria	8740
14	Hôpital Erasme/Erasmus Ziekenhuis	Bruxelles - Brussel		Belgium	1070
15	UZ Gent	Gent		Belgium	9000
16	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
17	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg	Germany	79106
18	Universitätsklinikum Aachen	Aachen	Nordrhein-Westfalen	Germany	52074
19	Frauenarztpraxis Dr. Bernd Pittner	Leipzig	Sachsen	Germany	04207
20	Praxis Dr. A. Schwenkhagen-Stodieck	Hamburg		Germany	20357
21	A.O.U. di Cagliari	Monserrato	Cagliari	Italy	09124
22	A.O.U. Policlinico - Vittorio Emanuele	Catania		Italy	95123
23	IRCCS Fondazione Maugeri - Montescano (Pavia)	Pavia		Italy	27100
24	A.O.U. Pisana	Pisa		Italy	56126
25	Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues	Gava	Barcelona	Spain	08850
26	Centro de Planificacion Familiar Alicante 3	Alicante		Spain	03013
27	USP Institut Universitari Dexeus	Barcelona		Spain	08028
28	Hospital Universitario Virgen de las Nieves	Granada		Spain	18014
29	Instituto Palacios de Salud y Medicina de la Mujer	Madrid		Spain	28009
30	Chulalongkorn Hospital	Bangkok		Thailand	10330
31	Ramathibodhi Hospital	Bangkok		Thailand	10400
32	Siriraj Hospital, Mahidol	Bangkok		Thailand	10700

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00764881
• Other Study ID Numbers: 91548; 2008-002263-13; 310785
• First Posted: Oct 2, 2008
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Oral contraceptive; Sexual dysfunction; Libido
• Additional relevant MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination

Study Results

Participant Flow

Recruitment Details	The date of first subject was 29 Jan 2009. The date of last subject was 20 Jul 2010.
Pre-assignment Detail	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).

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	108	109
Subjects Received Treatment	106	107
COMPLETED	92	99
NOT COMPLETED	16	10

Baseline Characteristics

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo	Total
Arm/Group Description	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.	Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.	Total of all reporting groups
Overall Participants	106	107	213
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (7.0)	30.2 (7.8)	30.5 (7.4)
Sex: Female, Male (Count of Participants)
Female	106 100%	107 100%	213 100%
Male	0 0%	0 0%	0 0%
Ethnic group (participants) [Number]
Caucasian	90 84.9%	92 86%	182 85.4%
Hispanic	0 0%	1 0.9%	1 0.5%
Asian	16 15.1%	13 12.1%	29 13.6%
Other	0 0%	1 0.9%	1 0.5%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	22.8 (3.2)	22.7 (2.9)	22.8 (3.0)

Outcome Measures

1. Primary Outcome

Title	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)
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [scores on a scale]	6.45 (5.33)	5.98 (6.22)

2. Primary Outcome

Title	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)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	92	95
Mean (Standard Deviation) [scores on a scale]	6.43 (5.36)	6.37 (5.86)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [scores on a scale]	2.51 (0.72)	2.39 (0.74)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [scores on a scale]	3.53 (0.95)	3.52 (0.89)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [scores on a scale]	1.02 (0.98)	1.11 (1.02)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [scores on a scale]	2.65 (0.94)	2.77 (0.83)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [scores on a scale]	4.03 (1.23)	4.05 (1.35)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [scores on a scale]	1.43 (1.25)	1.24 (1.53)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	3.56 (1.44)	3.73 (1.14)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [scores on a scale]	4.90 (1.18)	4.81 (1.46)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	1.36 (1.53)	1.04 (1.91)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	2.97 (1.41)	2.93 (1.24)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	4.22 (1.52)	4.05 (1.49)

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	1.26 (1.52)	1.06 (1.65)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	3.16 (1.06)	3.20 (0.78)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	4.19 (1.13)	4.26 (1.10)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	1.03 (1.24)	1.03 (1.20)

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	4.34 (1.78)	4.74 (1.52)

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	5.04 (1.53)	5.01 (1.55)

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	0.69 (1.83)	0.22 (1.89)

21. Secondary Outcome

Title	The Mean Absolute Values of FSFI Total Score at Baseline
Description	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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [scores on a scale]	19.2 (5.6)	19.8 (4.8)

22. Secondary Outcome

Title	The Mean Absolute Values of FSFI Total Score at Cycle 6
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	25.8 (6.5)	25.7 (6.8)

23. Secondary Outcome

Title	Mean Change From Baseline to Cycle 6 in FSFI Total Score
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Mean (Standard Deviation) [Scores on a scale]	6.7 (6.9)	5.7 (7.8)

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	25.6 (10.6)	27.5 (10.2)

25. Secondary Outcome

Title	The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
Description	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 Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	14.8 (10.2)	17.6 (11.4)

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	-10.0 (10.4)	-9.6 (10.5)

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	69.76 (10.85)	68.47 (11.98)

28. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	71.63 (11.72)	72.48 (10.57)

29. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	2.60 (11.26)	4.12 (10.71)

30. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	105	107
Mean (Standard Deviation) [Scores on a scale]	67.75 (6.78)	67.98 (7.36)

31. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	69.20 (8.32)	69.86 (6.95)

32. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	1.93 (8.11)	1.90 (7.23)

33. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	70.3 (15.7)	71.5 (16.1)

34. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	74.8 (16.0)	74.1 (15.6)

35. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	4.9 (14.9)	2.6 (15.4)

36. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	86.20 (11.38)	85.79 (12.16)

37. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	87.24 (13.15)	89.94 (9.61)

38. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	1.75 (13.17)	4.25 (11.38)

39. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	47.88 (9.05)	48.46 (6.53)

40. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	49.41 (6.63)	49.26 (6.23)

41. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	0.91 (9.81)	0.98 (7.55)

42. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	66.40 (9.35)	66.66 (8.36)

43. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	66.95 (9.53)	67.18 (8.33)

44. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	0.02 (12.21)	0.71 (9.84)

45. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	79.12 (14.75)	81.00 (13.74)

46. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	80.22 (13.95)	81.17 (13.31)

47. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	0.93 (15.57)	-0.15 (14.14)

48. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	60.27 (10.81)	60.93 (9.01)

49. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	61.83 (9.46)	63.58 (8.31)

50. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	1.42 (10.11)	2.65 (10.07)

51. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Number [Percentage of participants]	68.1 64.2%	70.5 65.9%

52. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Number [Percentage of participants]	70.3 66.3%	62.7 58.6%

53. Secondary Outcome

Title	Vaginal Effects Evaluated by Vaginal pH at Cycle 6
Description	Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	102
Vaginal pH < 4.0	0.053 0.1%	0.039 0%
Vaginal pH 4.0 - 4.4	0.298 0.3%	0.294 0.3%
Vaginal pH 4.5 - 5.0	0.521 0.5%	0.637 0.6%
Vaginal pH > 5.0	0.117 0.1%	0.029 0%

54. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	106	107
Mean (Standard Deviation) [Scores on a scale]	0.54 (0.55)	0.47 (0.48)

55. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	0.27 (0.40)	0.25 (0.36)

56. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	-0.27 (0.50)	-0.18 (0.38)

57. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	105	107
Mean (Standard Deviation) [Scores on a scale]	0.33 (0.14)	0.38 (0.26)

58. Secondary Outcome

Title	Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6
Description	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 Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	93	102
Mean (Standard Deviation) [Scores on a scale]	0.34 (0.15)	0.31 (0.12)

59. Secondary Outcome

Title	Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)
Description	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).
Time Frame	Baseline up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	92	102
Mean (Standard Deviation) [Scores on a scale]	0.01 (0.18)	-0.06 (0.27)

60. Secondary Outcome

Title	Number of Bleeding / Spotting Days in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	99
Mean (Standard Deviation) [Days]	16.3 (10.1)	15.3 (5.6)

61. Secondary Outcome

Title	Number of Bleeding / Spotting Days in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to 180 during study treatment
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	68	75
Mean (Standard Deviation) [Days]	12.2 (8.2)	12.6 (5.4)

62. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 1
Description	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
Time Frame	From Day 1 to Day 90

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	99
Mean (Standard Deviation) [episodes]	3.5 (1.5)	3.3 (1.3)

63. Secondary Outcome

Title	Number of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	68	75
Mean (Standard Deviation) [episodes]	3.0 (1.6)	3.1 (0.7)

64. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	90	99
Mean (Standard Deviation) [Days]	4.47 (2.44)	4.42 (1.36)

65. Secondary Outcome

Title	Mean Length of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	61	75
Mean (Standard Deviation) [Days]	4.13 (2.09)	4.03 (1.17)

66. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	90	99
Mean (Standard Deviation) [Days]	6.6 (4.7)	5.6 (2.6)

67. Secondary Outcome

Title	Maximum Length of Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	61	75
Mean (Standard Deviation) [Days]	5.3 (2.9)	4.7 (1.6)

68. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	90	99
Mean (Standard Deviation) [Days]	3.8 (4.5)	2.2 (2.7)

69. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	61	75
Mean (Standard Deviation) [Days]	2.3 (2.4)	1.3 (1.5)

70. Secondary Outcome

Title	Number of Spotting Only Days in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	99
Mean (Standard Deviation) [Days]	7.6 (7.8)	3.8 (3.9)

71. Secondary Outcome

Title	Number of Spotting Only Days in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	68	75
Mean (Standard Deviation) [Days]	6.1 (6.0)	3.3 (4.7)

72. Secondary Outcome

Title	Number of Spotting Only Episodes in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	94	99
Mean (Standard Deviation) [episodes]	1.1 (1.4)	0.4 (1.1)

73. Secondary Outcome

Title	Number of Spotting Only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	68	75
Mean (Standard Deviation) [episodes]	1.1 (1.5)	0.4 (1.1)

74. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	50	22
Mean (Standard Deviation) [Days]	3.38 (3.43)	2.79 (1.77)

75. Secondary Outcome

Title	Mean Length of Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	33	16
Mean (Standard Deviation) [Days]	3.18 (2.26)	3.23 (2.46)

76. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	50	22
Mean (Standard Deviation) [Days]	3.9 (3.5)	3.3 (2.4)

77. Secondary Outcome

Title	Maximum Length of Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	33	16
Mean (Standard Deviation) [Days]	3.9 (2.8)	3.7 (2.9)

78. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	50	22
Mean (Standard Deviation) [Days]	1.1 (1.6)	1.0 (1.9)

79. Secondary Outcome

Title	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2
Description	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.
Time Frame	From Day 91 to Day 180

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	33	16
Mean (Standard Deviation) [Days]	1.3 (2.0)	0.8 (1.7)

80. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	101	107
without withdrawal bleeding	24.8 23.4%	2.8 2.6%
with withdrawal bleeding	75.2 70.9%	97.2 90.8%

81. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	96	99
without withdrawal bleeding	13.5 12.7%	0.0 0%
with withdrawal bleeding	86.5 81.6%	100.0 93.5%

82. Secondary Outcome

Title	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	74	75
without withdrawal bleeding	51.4 48.5%	8.0 7.5%
with withdrawal bleeding	48.6 45.8%	92.0 86%

83. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 1
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	76	104
Mean (Standard Deviation) [Days]	4.3 (2.4)	4.6 (1.9)

84. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 3
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	83	99
Mean (Standard Deviation) [Days]	4.3 (2.6)	4.4 (1.5)

85. Secondary Outcome

Title	Length of Withdrawal Bleeding Episodes at Cycle 6
Description	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)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	36	69
Mean (Standard Deviation) [Days]	3.4 (1.4)	4.0 (1.3)

86. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
Description	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	76	104
Mean (Standard Deviation) [Scores on a scale]	3.1 (0.8)	3.7 (0.8)

87. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Description	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	83	99
Mean (Standard Deviation) [Scores on a scale]	3.2 (0.8)	3.8 (0.7)

88. Secondary Outcome

Title	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Description	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	36	69
Mean (Standard Deviation) [Scores on a scale]	3.0 (1.0)	3.6 (0.9)

89. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	76	104
spotting	22.4 21.1%	7.7 7.2%
light	44.7 42.2%	25.0 23.4%
normal	30.3 28.6%	53.8 50.3%
heavy	2.6 2.5%	13.5 12.6%

90. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
Description	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 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	83	99
spotting	26.5 25%	4.0 3.7%
light	33.7 31.8%	25.3 23.6%
normal	37.3 35.2%	61.6 57.6%
heavy	2.4 2.3%	9.1 8.5%

91. Secondary Outcome

Title	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6
Description	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 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	36	69
spotting	38.9 36.7%	13.0 12.1%
light	27.8 26.2%	26.1 24.4%
normal	27.8 26.2%	47.8 44.7%
heavy	5.6 5.3%	13.0 12.1%

92. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 1
Description	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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	76	104
Mean (Standard Deviation) [Days]	3.5 (5.0)	3.4 (2.3)

93. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 3
Description	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 3

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	83	99
Mean (Standard Deviation) [Days]	4.2 (6.5)	3.6 (2.6)

94. Secondary Outcome

Title	Onset of Withdrawal Bleeding Episodes at Cycle 6
Description	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 6

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	36	69
Mean (Standard Deviation) [Days]	1.1 (1.7)	3.3 (1.1)

95. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	101	107
with absence of intracyclic bleeding	84.2 79.4%	95.3 89.1%
with presence of intracyclic bleeding	15.8 14.9%	4.7 4.4%

96. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	96	99
with absence of intracyclic bleeding	82.3 77.6%	96.0 89.7%
with presence of intracyclic bleeding	17.7 16.7%	4.0 3.7%

97. Secondary Outcome

Title	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	74	75
with absence of intracyclic bleeding	83.8 79.1%	94.7 88.5%
with presence of intracyclic bleeding	16.2 15.3%	5.3 5%

98. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	101	107
Mean (Standard Deviation) [episodes]	0.2 (0.5)	0.1 (0.3)

99. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	96	99
Mean (Standard Deviation) [episodes]	0.2 (0.4)	0.1 (0.3)

100. Secondary Outcome

Title	Number of Intracyclic Bleeding Episodes at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	74	75
Mean (Standard Deviation) [episodes]	0.2 (0.4)	0.1 (0.3)

101. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	16	5
Mean (Standard Deviation) [Days]	3.5 (3.4)	2.4 (1.9)

102. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	17	4
Mean (Standard Deviation) [Days]	5.0 (5.2)	2.8 (2.4)

103. Secondary Outcome

Title	Maximum Length of Intracyclic Bleeding Episodes at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	12	4
Mean (Standard Deviation) [Days]	3.5 (1.4)	5.0 (5.7)

104. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 1
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 1 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	101	107
Mean (Standard Deviation) [Days]	0.6 (1.9)	0.1 (0.8)

105. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 3
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 3 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	96	99
Mean (Standard Deviation) [Days]	0.9 (2.9)	0.1 (0.7)

106. Secondary Outcome

Title	Number of Intracyclic Bleeding Days at Cycle 6
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	At Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	74	75
Mean (Standard Deviation) [Days]	0.6 (1.4)	0.3 (1.6)

107. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	16	5
spotting	75.0 70.8%	80.0 74.8%
light	6.3 5.9%	20.0 18.7%
normal	12.5 11.8%	0.0 0%
heavy	6.3 5.9%	0.0 0%

108. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	17	4
spotting	64.7 61%	75.0 70.1%
light	23.5 22.2%	25.0 23.4%
normal	11.8 11.1%	0.0 0%
heavy	0.0 0%	0.0 0%

109. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	12	4
spotting	66.7 62.9%	100.0 93.5%
light	8.3 7.8%	0.0 0%
normal	16.7 15.8%	0.0 0%
heavy	8.3 7.8%	0.0 0%

110. Secondary Outcome

Title	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode
Description	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.
Time Frame	Up to Cycle 6 (28 days per Cycle)

Outcome Measure Data

Analysis Population Description

All participants in FAS with assessment for this outcome measure.

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
Arm/Group Description	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.	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.
Measure Participants	103	107
no	63.1 59.5%	87.9 82.1%
yes	36.9 34.8%	12.1 11.3%

Adverse Events

Arm/Group Title	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)		EE/LNG (Microgynon) + Placebo
Arm/Group Description	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		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
All Cause Mortality
	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)		EE/LNG (Microgynon) + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)		EE/LNG (Microgynon) + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/106 (2.8%)		0/107 (0%)
Infections and infestations
Appendicitis	1/106 (0.9%)	1	0/107 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/106 (0.9%)	1	0/107 (0%)	0
Vascular disorders
Deep vein thrombosis	1/106 (0.9%)	1	0/107 (0%)	0
Other (Not Including Serious) Adverse Events
	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)		EE/LNG (Microgynon) + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/106 (30.2%)		11/107 (10.3%)
Infections and infestations
Bronchitis	3/106 (2.8%)	3	1/107 (0.9%)	1
Influenza	5/106 (4.7%)	5	2/107 (1.9%)	2
Pharyngitis	4/106 (3.8%)	4	1/107 (0.9%)	1
Upper respiratory tract infection	4/106 (3.8%)	5	2/107 (1.9%)	2
Injury, poisoning and procedural complications
Foot fracture	3/106 (2.8%)	3	0/107 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	3/106 (2.8%)	3	1/107 (0.9%)	1
Nervous system disorders
Headache	9/106 (8.5%)	31	5/107 (4.7%)	10
Migraine	3/106 (2.8%)	3	0/107 (0%)	0
Skin and subcutaneous tissue disorders
Acne	3/106 (2.8%)	3	1/107 (0.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Institution must ensure Discloser gives 40 days notice of proposed Publication to Sponsor who may within 40-day period: provide comments, Institution must consider such comments but is not bound to follow them; request delay of Publication for 120 days to allow Sponsor to file patent applications or take other measures to preserve its proprietary rights, Institution must abide by request; request Discloser remove specified Confidential Information, Institution must remove such Information.