NCT00384046

Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.

Detailed description

This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
DRUG	Testosterone	patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
DRUG	Placebo	patch, placebo, patch changed every 3-4 days, 24 weeks

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-10-04
• Last updated: 2013-04-17

Locations

31 sites across 5 countries: Australia, Botswana, Canada, Germany, United Kingdom