NCT00566384

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Libido

Interventions

Type	Name	Description
DRUG	Dehydroepiandrosterone, BAY86-5314	Treatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
DRUG	Placebo	Treatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-12-03
• Last updated: 2014-12-02

Locations

11 sites across 1 country: Germany