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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido | ||||
| Official Title † | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| 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 ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Decreased Libido | ||||
| Intervention † | Drug: Dehydroepiandrosterone Drug: Placebo |
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| MEDLINE PMIDs | |||||
| Links | Click here and search for drug information provided by the FDA ![]() Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  ![]() Click here to find results for studies related to marketed products  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | November 2007 | ||||
| Completion Date | May 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00566384 | ||||
| Organization ID | 91692 | ||||
| Secondary IDs †† | 310741, EudraCT No 2006-004397-27 | ||||
| Study Sponsor † | Bayer | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bayer | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | November 29, 2007 | ||||
| Last Updated Date | October 30, 2008 | ||||