Clinical Trial: Flibanserin Versus Placebo in Premenopausal Women With HSDD
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive
Brief Summary:
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
To evaluate safety and tolerability of flibanserin in such patients.
Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc
Current Primary Outcome: Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. [ Time Frame: baseline to 24 weeks ]
Original Primary Outcome: The primary endpoint is the change from baseline in the frequency of satisfying sexual events as measured by the eDiary. The comparison will be made between the four week baseline period and Week 21 to 24.
Current Secondary Outcome:
Original Secondary Outcome: The first key secondary endpoint is the change from baseline in the monthly sum of responses to the eDiary daily desire question. The second key secondary endpoint is the FSDS R
Information By: Sprout Pharmaceuticals, Inc
Dates:
Date Received: June 25, 2007
Date Started: June 2007
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014