NCT01235754

Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: BioSante Pharmaceuticals · Industry
• Sex: Female
• Age: 30 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	transdermal testosterone gel 1%	300 mcg once daily transdermal testosterone gel 1%
DRUG	placebo gel	once daily transdermal placebo gel

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-11-08
• Last updated: 2013-01-10

Locations

102 sites across 2 countries: United States, Canada