Clinical Trial: Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

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

Official Title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Dis

Brief Summary: This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal women

Detailed Summary:
Sponsor: BioSante Pharmaceuticals

Current Primary Outcome: Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score. [ Time Frame: Baseline and 21-24 weeks. ]

Original Primary Outcome: The change in the 4-week total number of days with at least one satisfying sexual event from the Baseline period to Weeks 21-24. [ Time Frame: Baseline and 21-24 weeks. ]

Current Secondary Outcome: Change from baseline over time for multiple efficacy measurements [ Time Frame: change over timepoints from baseline ]

Original Secondary Outcome: Change from baseline over time for multiple efficacy measurements [ Time Frame: change over timepoints from baseline period to weeks 21-24 ]

Information By: BioSante Pharmaceuticals

Dates:
Date Received: January 30, 2008
Date Started: December 2006
Date Completion:
Last Updated: January 4, 2013
Last Verified: January 2013