Clinical Trial: Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA

Brief Summary: To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome: Duration of efficacy of flibanserin in Sexually Satisfying Events [ Time Frame: 24 weeks ]

Original Primary Outcome: Co-primary endpoints are the changes from randomization baseline to the final visit for satisfying sexual events per month and the desire score monthly total.

Current Secondary Outcome:

Original Secondary Outcome: Time to the loss of response, rates of loss of response, and total scores of the FSDS-R during the double-blind period.

Information By: Sprout Pharmaceuticals, Inc

Dates:
Date Received: January 16, 2006
Date Started: January 2006
Date Completion:
Last Updated: March 14, 2012
Last Verified: March 2012