NCT00331123

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

Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 562 (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 52-week, multicenter, multinational study that included a 24-week, double-blind (DB), parallel-group, placebo-controlled period followed by a 28-week open-label (OL) period. 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. Upon completion of the DB period, patients receiving placebo were switched to TTS, while the active cohort remained on active treatment. All patients were then followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of the study were given the opportunity to participate in an open label extension (Years 2, 3 , and 4), which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, coagulation testing, 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, 300mcg/day, changed every 3-4 days for up to 52 weeks
DRUG	Placebo	placebo patch,changed every 3-4 days for 24 weeks during double blind phase

Timeline

• Start date: 2002-05-01
• 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