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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00566384 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 100 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1 |
Drug: Dehydroepiandrosterone, BAY86-5314
Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
|
Eligibility| 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:
Contacts and Locations| Germany | |
| Berlin, Germany, 13357 | |
| Berlin, Germany, 13086 | |
| Berlin, Germany, 13342 | |
| Berlin, Germany, 10627 | |
| Berlin, Germany, 12435 | |
| Berlin, Germany, 10115 | |
| Berlin, Germany, 10247 | |
| Berlin, Germany, 10709 | |
| Berlin, Germany, 10629 | |
| Berlin, Germany, 14195 | |
| Hamburg, Germany, 22143 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00566384 History of Changes |
| Other Study ID Numbers: | 91692, 310741, EudraCT No 2006-004397-27 |
| Study First Received: | November 29, 2007 |
| Last Updated: | June 8, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Loss of libido Acquired, oral contraceptive -associated female sexual dysfunction |
|
Contraceptive Agents Contraceptives, Oral Dehydroepiandrosterone Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Adjuvants, Immunologic Immunologic Factors |