Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Study Overview
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Brief Summary
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This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Official Title
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Drug: testosterone gel
* Drug: placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal female subjects at least 50 years of age with at least two points of cardiovascular risk with a clinical diagnosis of HSDD. Exclusion Criteria: Subjects must not require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators, have used androgen therapy within 2 months of randomization, have a history of estrogen-dependent neoplasia or any gynecologic cancer, have a history of cancer of any kind in the past 10 years prior to randomization, have a history of malignant melanoma or a history of invasive cancer at any time, have a screening mammogram with any finding that requires follow up within 6 months of randomization, have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization, have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Experimental: testosterone gel<br>1% testosterone transdermal gel | Drug: testosterone gel<br>* once daily transdermal testosterone gel, 300 mcg<br>* Other names: LibiGel;|
| Placebo Comparator: placebo gel<br>placebo transdermal gel | Drug: placebo gel<br>* once daily transdermal placebo gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects. |  | 2011 primary outcome analysis for NDA submission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular event, Breast Cancer, Testosterone, Menopause, Hypoactive Sexual Desire Disorder