NCT00349791

Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 24 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

Detailed description

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were randomized to receive a placebo or testosterone transdermal system throughout the study. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Conditions

• Hypoactive Sexual Desire Disorder (HSDD)

Interventions

Type	Name	Description
DRUG	Testosterone Transdermal System	testosterone (300 mcg/day) patch replaced twice a week for two years
DRUG	Placebo patch	placebo patch replaced twice a week for two years

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2006-07-10
• Last updated: 2013-04-17

Locations

3 sites across 3 countries: United States, Australia, Canada