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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00566384 |
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.
Condition | Intervention | Phase |
---|---|---|
Decreased Libido |
Drug: Dehydroepiandrosterone, BAY86-5314 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator |
Drug: Dehydroepiandrosterone, BAY86-5314
Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
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Arm 2: Placebo Comparator |
Drug: Placebo
Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prohibited concomitant medication:
Germany | |
Berlin, Germany, 10115 | |
Berlin, Germany, 10247 | |
Berlin, Germany, 10709 | |
Berlin, Germany, 13357 | |
Berlin, Germany, 13086 | |
Hamburg, Germany, 22143 | |
Berlin, Germany, 10627 | |
Berlin, Germany, 10629 | |
Berlin, Germany, 14195 | |
Berlin, Germany, 12435 | |
Berlin, Germany, 13342 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91692, 310741, EudraCT No 2006-004397-27 |
Study First Received: | November 29, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00566384 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Loss of libido Acquired, oral contraceptive -associated female sexual dysfunction |
Dehydroepiandrosterone |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |