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 ]

To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"


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