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Effects of SH T00658ID on Libido

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00764881
First received: October 1, 2008
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Contraception
Libido
Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Drug: Microgynon
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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  
[1] Full Analysis Set (FAS)



  Baseline Characteristics
  Hide Baseline Characteristics

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  



  Outcome Measures
  Show All Outcome Measures

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) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

3.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 3

4.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
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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) ]
  Show Outcome Measure 5

6.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 6

7.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 7

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) ]
  Show Outcome Measure 8

9.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 9

10.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 10

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) ]
  Show Outcome Measure 11

12.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 12

13.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 13

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) ]
  Show Outcome Measure 14

15.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 15

16.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 16

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) ]
  Show Outcome Measure 17

18.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.   [ Time Frame: At Baseline ]
  Show Outcome Measure 18

19.  Secondary:   The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 19

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) ]
  Show Outcome Measure 20

21.  Secondary:   The Mean Absolute Values of FSFI Total Score at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 21

22.  Secondary:   The Mean Absolute Values of FSFI Total Score at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 22

23.  Secondary:   Mean Change From Baseline to Cycle 6 in FSFI Total Score   [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 23

24.  Secondary:   The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 24

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) ]
  Hide Outcome Measure 25

Measure Type Secondary
Measure Title The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants in FAS with assessment for this outcome measure.

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.

Measured Values
    EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)     EE/LNG (Microgynon) + Placebo  
Number of Participants Analyzed  
[units: participants]
 		  93     102  
The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6  
[units: Scores on a scale]
Mean ± Standard Deviation 		  14.8  ± 10.2     17.6  ± 11.4  

No statistical analysis provided for The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6



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) ]
  Show Outcome Measure 26

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 ]
  Show Outcome Measure 27

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) ]
  Show Outcome Measure 28

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) ]
  Show Outcome Measure 29

30.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 30

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) ]
  Show Outcome Measure 31

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) ]
  Show Outcome Measure 32

33.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 33

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) ]
  Show Outcome Measure 34

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) ]
  Show Outcome Measure 35

36.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 36

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) ]
  Show Outcome Measure 37

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) ]
  Show Outcome Measure 38

39.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 39

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) ]
  Show Outcome Measure 40

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) ]
  Show Outcome Measure 41

42.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 42

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) ]
  Show Outcome Measure 43

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) ]
  Show Outcome Measure 44

45.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 45

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) ]
  Show Outcome Measure 46

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) ]
  Show Outcome Measure 47

48.  Secondary:   The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 48

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) ]
  Show Outcome Measure 49

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) ]
  Show Outcome Measure 50

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) ]
  Show Outcome Measure 51

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) ]
  Show Outcome Measure 52

53.  Secondary:   Vaginal Effects Evaluated by Vaginal pH at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
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54.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 54

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) ]
  Show Outcome Measure 55

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) ]
  Show Outcome Measure 56

57.  Secondary:   Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline   [ Time Frame: At Baseline ]
  Show Outcome Measure 57

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) ]
  Show Outcome Measure 58

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) ]
  Show Outcome Measure 59

60.  Secondary:   Number of Bleeding / Spotting Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
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61.  Secondary:   Number of Bleeding / Spotting Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 61

62.  Secondary:   Number of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 62

63.  Secondary:   Number of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 63

64.  Secondary:   Mean Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 64

65.  Secondary:   Mean Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 65

66.  Secondary:   Maximum Length of Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 66

67.  Secondary:   Maximum Length of Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 67

68.  Secondary:   Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 68

69.  Secondary:   Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 69

70.  Secondary:   Number of Spotting Only Days in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
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71.  Secondary:   Number of Spotting Only Days in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 71

72.  Secondary:   Number of Spotting Only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
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73.  Secondary:   Number of Spotting Only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 73

74.  Secondary:   Mean Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 74

75.  Secondary:   Mean Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 75

76.  Secondary:   Maximum Length of Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 76

77.  Secondary:   Maximum Length of Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 77

78.  Secondary:   Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1   [ Time Frame: From Day 1 to Day 90 ]
  Show Outcome Measure 78

79.  Secondary:   Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2   [ Time Frame: From Day 91 to Day 180 ]
  Show Outcome Measure 79

80.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 80

81.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 81

82.  Secondary:   Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 82

83.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 83

84.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 84

85.  Secondary:   Length of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 85

86.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 86

87.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 87

88.  Secondary:   Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 88

89.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 89

90.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 90

91.  Secondary:   Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 91

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 ]
  Show Outcome Measure 92

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 ]
  Show Outcome Measure 93

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 ]
  Show Outcome Measure 94

95.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 95

96.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 96

97.  Secondary:   Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 97

98.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 98

99.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 99

100.  Secondary:   Number of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 100

101.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 101

102.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 102

103.  Secondary:   Maximum Length of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 103

104.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 104

105.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 105

106.  Secondary:   Number of Intracyclic Bleeding Days at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 106

107.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1   [ Time Frame: At Cycle 1 (28 days per Cycle) ]
  Show Outcome Measure 107

108.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3   [ Time Frame: At Cycle 3 (28 days per Cycle) ]
  Show Outcome Measure 108

109.  Secondary:   Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6   [ Time Frame: At Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 109

110.  Secondary:   Percentage of Participants With at Least 1 Intracyclic Bleeding Episode   [ Time Frame: Up to Cycle 6 (28 days per Cycle) ]
  Show Outcome Measure 110


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00764881     History of Changes
Other Study ID Numbers: 91548, 2008-002263-13, 310785
Study First Received: October 1, 2008
Results First Received: July 28, 2011
Last Updated: March 12, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration