| November 29, 2007 |
| April 27, 2009 |
| November 2007 |
| March 2009 (final data collection date for primary outcome measure) |
| FSDS questionnaire (sexual desire and arousal component scores) [ Time Frame: at baseline and after 6 weeks of treatment ] [ Designated as safety issue: No ] |
| Change in sexual desire and arousal component scores of the FSFI (Female Sexual Function Index) questionnaire after 6 month treatment. [ Time Frame: 6 months ] |
| Complete list of historical versions of study NCT00566384 on ClinicalTrials.gov Archive Site |
- Change from baseline period to cycle 6 in the number of satisfactory sexual events [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]
- FSFI questionnaire (absolute values and change from baseline) - All domains [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
- FSDS-R questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
- FSEP questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
- PGWBI questionnaire results [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
- Serum hormone levels (SHBG, T, DHEA, DHEA-S) [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
- Vaginal pH [ Time Frame: Cycle 1, 3, 6 and follow-up ] [ Designated as safety issue: No ]
|
| Other parameters of sexual function, general well-being, hormone levels and vaginal pH [ Time Frame: 6 months ] |
| |
| Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido |
| Multi-Center, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Daily Oral 100 mg Dehydroepiandrosterone (DHEA) Over 6 Treatment Cycles as a Concomitant Therapy to Oral Contraceptives (OC) to Alleviate Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With OC-Use |
The purpose of the study is to evaluate the effectiveness of the study drug on the libido (sexual desire) of women who are taking oral contraceptives and who have experienced libido reductions as a side-effect of this contraceptive method The hypothesis is that there is superiority in the change in sexual desire and arousal component scores of the FSFI questionnaire from baseline to cycle 6 of the treatment with the study drug as compared to Placebo. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Decreased Libido |
- Drug: Dehydroepiandrosterone, BAY86-5314
- Drug: Placebo
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| |
| |
| |
| Completed |
| 100 |
| April 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Treatment with a oral contraceptive (OC) for at least 3 months and willing to continue the OC
- Loss of libido
- Sexual relationship with a sexually competent partner
Exclusion Criteria:
|
| Female |
| 18 Years to 35 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00566384 |
| Therapeutic Area Head, Bayer Schering Pharma AG |
| 91692, 310741, EudraCT No 2006-004397-27 |
| Bayer |
|
| Study Director: |
Bayer Study Director |
Bayer |
|
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| Bayer |
| April 2009 |