NCT00131495

Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 814 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.

Detailed description

Detailed Description: Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	Testosterone (transdermal patches)	Testosterone patch (300mcg/day, changed twice a week for one year
DRUG	Placebo patch	placebo patch changed twice a week for one year

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-02-01
• Completion: 2007-02-01
• First posted: 2005-08-18
• Last updated: 2013-04-17

Locations

1 site across 1 country: Australia