Clinical Trial: A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD

Brief Summary: To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome: The Frequency of Adverse Events (Side Effects). [ Time Frame: 52 weeks ]

This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder


Original Primary Outcome: The Frequency of Adverse Events (Side Effects).

Current Secondary Outcome:

Original Secondary Outcome: Clinically significant changes to physical exam, pelvic exam, vital signs, ECG, labs, eye exams, and overall patient status. Additionally, patients must complete questionnaires related to sexual health, depression and suicidal thoughts.

Information By: Sprout Pharmaceuticals, Inc

Dates:
Date Received: February 28, 2007
Date Started: February 2007
Date Completion:
Last Updated: May 14, 2014
Last Verified: May 2014