NCT00331214

Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido

Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 533 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 20 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 surgically menopausal women who are taking estrogen therapy.

Detailed description

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on their use of oral or transdermal ET and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen throughout the study. Patients who completed the first 24 weeks of the study were given the opportunity to participate in a 3.5 year open-label (active treatment) study extension which was added to the protocol by amendment. 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

Interventions

Type	Name	Description
DRUG	Testosterone Transdermal System	testosterone patch (300 mcg/day), patch changed twice a week for six months
DRUG	placebo patch	placebo patch replaced every 3-4 days for 6 months

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-12-01
• Completion: 2006-07-01
• First posted: 2006-05-29
• Last updated: 2013-04-17

Locations

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