Effects of SH T00658ID on Libido

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The date of first subject was 29 Jan 2009. The date of last subject was 20 Jul 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
EE/LNG (Microgynon) + Placebo	Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.

Participant Flow:   Overall Study

	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo
STARTED	108	109
Subjects Received Treatment	106 [1]	107 [1]
COMPLETED	92	99
NOT COMPLETED	16	10
Adverse Event	5	1
Withdrawal by Subject	1	3
Protocol Violation	2	2
Lost to Follow-up	2	0
Noncompliant	1	0
Accidentally discontinued study drug	1	0
Wished to become pregnant	1	0
Carcinoma detected	1	0
Possibly noncompliant (study drug)	0	2
no treatment or no observation	2	2

Reporting Groups

	Description
EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
EE/LNG (Microgynon) + Placebo	Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Total	Total of all reporting groups

Baseline Measures

	EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)	EE/LNG (Microgynon) + Placebo	Total
Number of Participants   [units: participants]	106	107	213
Age   [units: years] Mean ± Standard Deviation	30.9  ± 7.0	30.2  ± 7.8	30.5  ± 7.4
Gender   [units: participants]
Female	106	107	213
Male	0	0	0
Ethnic group   [units: participants]
Caucasian	90	92	182
Hispanic	0	1	1
Asian	16	13	29
Other	0	1	1
Body Mass Index (BMI)   [units: kg/m^2] Mean ± Standard Deviation	22.8  ± 3.2	22.7  ± 2.9	22.8  ± 3.0

1.  Primary:

Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

2.  Primary:

Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

3.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline   [ Time Frame: At Baseline ]

4.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

5.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

6.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline   [ Time Frame: At Baseline ]

7.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

8.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

9.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline   [ Time Frame: At Baseline ]

10.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

11.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

12.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline   [ Time Frame: At Baseline ]

13.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

14.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

15.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline   [ Time Frame: At Baseline ]

16.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

17.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

18.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.   [ Time Frame: At Baseline ]

19.  Secondary:

The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

20.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

21.  Secondary:

The Mean Absolute Values of FSFI Total Score at Baseline   [ Time Frame: At Baseline ]

22.  Secondary:

The Mean Absolute Values of FSFI Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

23.  Secondary:

Mean Change From Baseline to Cycle 6 in FSFI Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

24.  Secondary:

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline   [ Time Frame: At Baseline ]

25.  Secondary:

The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

26.  Secondary:

Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

27.  Secondary:

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline   [ Time Frame: At Baseline ]

28.  Secondary:

The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

29.  Secondary:

Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

30.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline   [ Time Frame: At Baseline ]

31.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

32.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

33.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline   [ Time Frame: At Baseline ]

34.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

35.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

36.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline   [ Time Frame: At Baseline ]

37.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

38.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

39.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline   [ Time Frame: At Baseline ]

40.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

41.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

42.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline   [ Time Frame: At Baseline ]

43.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

44.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

45.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline   [ Time Frame: At Baseline ]

46.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

47.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

48.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline   [ Time Frame: At Baseline ]

49.  Secondary:

The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

50.  Secondary:

Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

51.  Secondary:

Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

52.  Secondary:

Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

53.  Secondary:

Vaginal Effects Evaluated by Vaginal pH at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

54.  Secondary:

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline   [ Time Frame: At Baseline ]

55.  Secondary:

Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

56.  Secondary:

Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]

57.  Secondary:

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline   [ Time Frame: At Baseline ]

58.  Secondary:

Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

59.  Secondary:

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

60.  Secondary:

Number of Bleeding / Spotting Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

61.  Secondary:

Number of Bleeding / Spotting Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

62.  Secondary:

Number of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

63.  Secondary:

Number of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

64.  Secondary:

Mean Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

65.  Secondary:

Mean Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

66.  Secondary:

Maximum Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

67.  Secondary:

Maximum Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

68.  Secondary:

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

69.  Secondary:

Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

70.  Secondary:

Number of Spotting Only Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

71.  Secondary:

Number of Spotting Only Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

72.  Secondary:

Number of Spotting Only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

73.  Secondary:

Number of Spotting Only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

74.  Secondary:

Mean Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

75.  Secondary:

Mean Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

76.  Secondary:

Maximum Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

77.  Secondary:

Maximum Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

78.  Secondary:

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]

79.  Secondary:

Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]

80.  Secondary:

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

81.  Secondary:

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

82.  Secondary:

Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

83.  Secondary:

Length of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

84.  Secondary:

Length of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

85.  Secondary:

Length of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

86.  Secondary:

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

87.  Secondary:

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

88.  Secondary:

Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

89.  Secondary:

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

90.  Secondary:

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

91.  Secondary:

Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

92.  Secondary:

Onset of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1 ]

93.  Secondary:

Onset of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3 ]

94.  Secondary:

Onset of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6 ]

95.  Secondary:

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

96.  Secondary:

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

97.  Secondary:

Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

98.  Secondary:

Number of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

99.  Secondary:

Number of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

100.  Secondary:

Number of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

101.  Secondary:

Maximum Length of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

102.  Secondary:

Maximum Length of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

103.  Secondary:

Maximum Length of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

104.  Secondary:

Number of Intracyclic Bleeding Days at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

105.  Secondary:

Number of Intracyclic Bleeding Days at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

106.  Secondary:

Number of Intracyclic Bleeding Days at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

107.  Secondary:

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]

108.  Secondary:

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]

109.  Secondary:

Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]

110.  Secondary:

Percentage of Participants With at Least 1 Intracyclic Bleeding Episode   [ Time Frame: Up to Cycle 6 (28 days per Cycle) ]