Phase 3
N=217
Effects of SH T00658ID on Libido
Contraception · Libido
Bottom Line
View on ClinicalTrials.gov: NCT00764881 ↗Enrolled (actual)
217
Serious AEs
1.4%
Results posted
Apr 2012
Primary outcome: 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) — 6.45; 5.98 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EV/DNG (Qlaira, BAY86-5027, SH T00658ID) (Drug); Microgynon (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
6.45; 5.98 | — |
| 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) |
6.43; 6.37 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline |
2.51; 2.39 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6 |
3.53; 3.52 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire) |
1.02; 1.11 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline |
2.65; 2.77 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6 |
4.03; 4.05 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal) |
1.43; 1.24 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline |
3.56; 3.73 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6 |
4.90; 4.81 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication) |
1.36; 1.04 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline |
2.97; 2.93 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6 |
4.22; 4.05 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm) |
1.26; 1.06 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline |
3.16; 3.20 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6 |
4.19; 4.26 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction) |
1.03; 1.03 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline. |
4.34; 4.74 | — |
| SECONDARY The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6 |
5.04; 5.01 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain) |
0.69; 0.22 | — |
| SECONDARY The Mean Absolute Values of FSFI Total Score at Baseline |
19.2; 19.8 | — |
| SECONDARY The Mean Absolute Values of FSFI Total Score at Cycle 6 |
25.8; 25.7 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in FSFI Total Score |
6.7; 5.7 | — |
| SECONDARY The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline |
25.6; 27.5 | — |
| SECONDARY The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6 |
14.8; 17.6 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score |
-10.0; -9.6 | — |
| SECONDARY The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline |
69.76; 68.47 | — |
| SECONDARY The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6 |
71.63; 72.48 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score |
2.60; 4.12 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline |
67.75; 67.98 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6 |
69.20; 69.86 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score |
1.93; 1.90 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline |
70.3; 71.5 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6 |
74.8; 74.1 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety |
4.9; 2.6 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline |
86.20; 85.79 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6 |
87.24; 89.94 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood |
1.75; 4.25 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline |
47.88; 48.46 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6 |
49.41; 49.26 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being |
0.91; 0.98 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline |
66.40; 66.66 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6 |
66.95; 67.18 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control |
0.02; 0.71 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline |
79.12; 81.00 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6 |
80.22; 81.17 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health |
0.93; -0.15 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline |
60.27; 60.93 | — |
| SECONDARY The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6 |
61.83; 63.58 | — |
| SECONDARY Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality |
1.42; 2.65 | — |
| SECONDARY Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6 |
68.1; 70.5 | — |
| SECONDARY Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6 |
70.3; 62.7 | — |
| SECONDARY Vaginal Effects Evaluated by Vaginal pH at Cycle 6 |
0.053; 0.039; 0.298; 0.294; 0.521; 0.637 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline |
0.54; 0.47 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6 |
0.27; 0.25 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ) |
-0.27; -0.18 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline |
0.33; 0.38 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6 |
0.34; 0.31 | — |
| SECONDARY Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA) |
0.01; -0.06 | — |
| SECONDARY Number of Bleeding / Spotting Days in Reference Period 1 |
16.3; 15.3 | — |
| SECONDARY Number of Bleeding / Spotting Days in Reference Period 2 |
12.2; 12.6 | — |
| SECONDARY Number of Bleeding / Spotting Episodes in Reference Period 1 |
3.5; 3.3 | — |
| SECONDARY Number of Bleeding / Spotting Episodes in Reference Period 2 |
3.0; 3.1 | — |
| SECONDARY Mean Length of Bleeding / Spotting Episodes in Reference Period 1 |
4.47; 4.42 | — |
| SECONDARY Mean Length of Bleeding / Spotting Episodes in Reference Period 2 |
4.13; 4.03 | — |
| SECONDARY Maximum Length of Bleeding / Spotting Episodes in Reference Period 1 |
6.6; 5.6 | — |
| SECONDARY Maximum Length of Bleeding / Spotting Episodes in Reference Period 2 |
5.3; 4.7 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1 |
3.8; 2.2 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2 |
2.3; 1.3 | — |
| SECONDARY Number of Spotting Only Days in Reference Period 1 |
7.6; 3.8 | — |
| SECONDARY Number of Spotting Only Days in Reference Period 2 |
6.1; 3.3 | — |
| SECONDARY Number of Spotting Only Episodes in Reference Period 1 |
1.1; 0.4 | — |
| SECONDARY Number of Spotting Only Episodes in Reference Period 2 |
1.1; 0.4 | — |
| SECONDARY Mean Length of Spotting-only Episodes in Reference Period 1 |
3.38; 2.79 | — |
| SECONDARY Mean Length of Spotting-only Episodes in Reference Period 2 |
3.18; 3.23 | — |
| SECONDARY Maximum Length of Spotting-only Episodes in Reference Period 1 |
3.9; 3.3 | — |
| SECONDARY Maximum Length of Spotting-only Episodes in Reference Period 2 |
3.9; 3.7 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1 |
1.1; 1.0 | — |
| SECONDARY Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2 |
1.3; 0.8 | — |
| SECONDARY Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 |
24.8; 2.8; 75.2; 97.2 | — |
| SECONDARY Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 |
13.5; 0.0; 86.5; 100.0 | — |
| SECONDARY Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 |
51.4; 8.0; 48.6; 92.0 | — |
| SECONDARY Length of Withdrawal Bleeding Episodes at Cycle 1 |
4.3; 4.6 | — |
| SECONDARY Length of Withdrawal Bleeding Episodes at Cycle 3 |
4.3; 4.4 | — |
| SECONDARY Length of Withdrawal Bleeding Episodes at Cycle 6 |
3.4; 4.0 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 |
3.1; 3.7 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 |
3.2; 3.8 | — |
| SECONDARY Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 |
3.0; 3.6 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 |
22.4; 7.7; 44.7; 25.0; 30.3; 53.8 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 |
26.5; 4.0; 33.7; 25.3; 37.3; 61.6 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 |
38.9; 13.0; 27.8; 26.1; 27.8; 47.8 | — |
| SECONDARY Onset of Withdrawal Bleeding Episodes at Cycle 1 |
3.5; 3.4 | — |
| SECONDARY Onset of Withdrawal Bleeding Episodes at Cycle 3 |
4.2; 3.6 | — |
| SECONDARY Onset of Withdrawal Bleeding Episodes at Cycle 6 |
1.1; 3.3 | — |
| SECONDARY Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 |
84.2; 95.3; 15.8; 4.7 | — |
| SECONDARY Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 |
82.3; 96.0; 17.7; 4.0 | — |
| SECONDARY Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 |
83.8; 94.7; 16.2; 5.3 | — |
| SECONDARY Number of Intracyclic Bleeding Episodes at Cycle 1 |
0.2; 0.1 | — |
| SECONDARY Number of Intracyclic Bleeding Episodes at Cycle 3 |
0.2; 0.1 | — |
| SECONDARY Number of Intracyclic Bleeding Episodes at Cycle 6 |
0.2; 0.1 | — |
| SECONDARY Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 |
3.5; 2.4 | — |
| SECONDARY Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 |
5.0; 2.8 | — |
| SECONDARY Maximum Length of Intracyclic Bleeding Episodes at Cycle 6 |
3.5; 5.0 | — |
| SECONDARY Number of Intracyclic Bleeding Days at Cycle 1 |
0.6; 0.1 | — |
| SECONDARY Number of Intracyclic Bleeding Days at Cycle 3 |
0.9; 0.1 | — |
| SECONDARY Number of Intracyclic Bleeding Days at Cycle 6 |
0.6; 0.3 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 |
75.0; 80.0; 6.3; 20.0; 12.5; 0.0 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 |
64.7; 75.0; 23.5; 25.0; 11.8; 0.0 | — |
| SECONDARY Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 |
66.7; 100.0; 8.3; 0.0; 16.7; 0.0 | — |
| SECONDARY Percentage of Participants With at Least 1 Intracyclic Bleeding Episode |
63.1; 87.9; 36.9; 12.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00764881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.