NCT00613002

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

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 Disorder in Surgically Menopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 597 (actual)
• Sponsor: BioSante Pharmaceuticals · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	testosterone gel	once daily transdermal testosterone gel, 300 mcg
DRUG	placebo gel	once daily transdermal placebo gel

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-02-12
• Last updated: 2013-01-10

Locations

63 sites across 2 countries: United States, Canada