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

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

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Drug: Testosterone Transdermal System
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>28 cm² Placebo patch | Drug: Placebo patch<br>* placebo patch, changed twice a week for 52 weeks<br>|
| Experimental: Testosterone<br>Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks | Drug: Testosterone Transdermal System<br>* Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Natural Menopause