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

08:17 EDT 29th August 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

Clinical Trials [1223 Associated Clinical Trials listed on BioPortfolio]

Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopaus...

Testosterone in Female Hypoactive Sexual Desire Disorder

The success of sildenafil in the treatment of erectile dysfunction has led to efforts to find similar treatments for prevalent disorders of female sexual dysfunction. Daily transdermal tes...

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

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 p...

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

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.

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

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 thera...

PubMed Articles [14875 Associated PubMed Articles listed on BioPortfolio]

Implications of off-label use: An example from the final results of an observational cohort study on Intrinsa® (testosterone patch).

Off-label use is where a medicinal product is used for a medical purpose not in accordance with the authorised product information. Intrinsa® is a transdermal testosterone patch, which is indicated f...

A Double-Blind, Placebo-Controlled Study of Selegiline Transdermal System in Depressed Adolescents.

Abstract Objective: A randomized, double-blind, placebo-controlled flexible-dose, parallel group trial was conducted at 26 clinical investigational sites in the United States to examine the safety and...

Testosterone Deficiency, Cardiac Health, and Older Men.

Low levels of testosterone are manifested by erectile dysfunction, reduced sexual desire, and loss of morning erections with increasing numbers of men are being diagnosed and require treatment. The pr...

Clinical evaluation of root tubers of Shweta Musali (Chlorophytum borivilianum L.) and its effect on semen and testosterone.

Shweta Musali (Chlorophytum borivilianum (CB)) is a traditionally used herb for its benefits in male sexual and general health. In the recent past, the herb has attained much commercial significance,...

Relationship between sexual function, body mass index and levels of sex steroid hormones in young men.

In older men, sexual disorders may be the result of a decrease in testosterone and an increase in sex hormone bindingglobulin (SHBG) serum levels. Although obesity may enhance the decline of testoster...

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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