Study of Transdermal Testosterone Patches in Surgically 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 surgically menopausal women who are taking estrogen therapy.

Detailed Description
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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.

Official Title
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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.

Conditions
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Hypoactive Sexual Desire Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible women must: Be 20-70 years old and in generally good health Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening Be receiving a stable dose of estrogen 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 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 P&GP study 1999068 or 1999092 Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

Ages Eligible for Study
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Minimum Age: 20 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: Placebo<br>Placebo patch | Drug: Placebo<br>* placebo patch,changed every 3-4 days for 24 weeks during double blind phase<br>|
| Experimental: Testosterone Patch<br> | Drug: Testosterone Transdermal System<br>* testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of testosterone 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). |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints. |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical menopause, HSDD