Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

Phase 3

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: Placebo patch; Drug: Testosterone Transdermal System

• Registration Number: NCT00467259
• Lead Sponsor: Warner Chilcott

Brief Summary

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

Detailed Description

Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2011-08-03
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Results First Posted: 2011-12-15
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1271

Inclusion Criteria

• Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.

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Exclusion Criteria

• Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo patch	28 cm² Placebo patch
Testosterone	Testosterone Transdermal System	Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1	52 weeks	Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Secondary Outcome Measures

Name	Time	Method
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1	52 weeks	Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1	52 weeks	Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies

Trial Locations

Locations (5)

Research Facility; 🇺🇸 Tacoma, Washington, United States

Study Facility; 🇺🇸 Richmond, Virginia, United States

Site Facility; 🇺🇸 Seattle, Washington, United States

Test Facility; 🇺🇸 Tacoma, Washington, United States

Research Site; 🇺🇸 Charleston, West Virginia, United States