Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00331123
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sexual Dysfunctions, Psychological
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)
Pedophilia
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).
Testosterone Congeners
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.
Satiation
Full gratification of a need or desire followed by a state of relative insensitivity to that particular need or desire.
Schizoid Personality Disorder
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.
Clinical Trials
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...
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
ISSM Health Policy Statement: Hypoactive Sexual Desire Disorder in Women.
Prevalence of Women's Sexual Desire Problems: What Criteria Do We Use?
Problems of sexual desire are often cited as the most prevalent of the female sexual dysfunctions. Despite this finding, considerable variability exists when comparing prevalence figures across studie...
Sexual dysfunction among young married women in southern India.
INTRODUCTION AND HYPOTHESIS: This study aimed to identify the nature, prevalence, and factors associated with female sexual disorders (FSD). METHODS: We assessed 150 women using the following instrume...
Abstract Objective: To determine the most appropriate cutoff value for the Sexual Interest and Desire Inventory-Female (SIDI-F) score to discriminate between women with hypoactive sexual desire disord...
Sexual dysfunction is highly prevalent in the general population and associated with psychological distress and impaired sexual satisfaction. Psychological interventions are promising treatment option...
