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

Study Overview
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Brief Summary
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This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

Detailed Description
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Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 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 metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.

Official Title
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A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.

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: Eligible women must: Be 40-70 years old and in generally good health Be post-menopausal with no spontaneous periods for 1 year Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen. Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry Meet the criteria for having hypoactive sexual desire disorder Exclusion Criteria: Eligible women must not: Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product) Be experiencing any chronic or acute life stress relating to any major life change Be experiencing depression and/or receiving medication for such illness or disorder Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages) Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years Have abnormal laboratory test results upon initial screening for this study Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo patch | Drug: Placebo patch<br>* placebo patch changed twice a week for one year<br>|
| Experimental: 2<br>testosterone patch (300 mcg/day) patch changed 2 times/week, for one year | Drug: Testosterone Transdermal System<br>* testosterone patch (300 mcg/day) patch changed 2 times/week, for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints. |  | 12 months | 

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