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

09:23 EDT 20th April 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Hypoactive Sexual Desire Disorder

Intervention

Testosterone Transdermal System, Placebo

Location

Research Site
Kansas City
Missouri
United States

Status

Completed

Source

Warner Chilcott

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Disturbances in sexual desire and the psychophysiologic changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty. (APA, DSM-IV, 1994)

A sexual disorder occurring in a person 16 years or older and that is recurrent with intense sexually arousing fantasies, sexual urges, or behaviors involving sexual activity with a prepubescent child (generally age 13 or younger). (from APA, DSM-IV, 1994).

Steroidal compounds related to TESTOSTERONE, the major mammalian male sex hormone. Testosterone congeners include important testosterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with androgenic activities.

Full gratification of a need or desire followed by a state of relative insensitivity to that particular need or desire.

A personality disorder manifested by a profound defect in the ability to form social relationships, no desire for social involvement, and an indifference to praise or criticism.

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