Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido

Libido Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Libido

• NCT number: NCT00566384
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: April 2009