Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido - Full Text View

Sponsor:	Warner Chilcott
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00331214

Purpose

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.

Condition	Intervention	Phase
Hypoactive Sexual Desire Disorder	Drug: Testosterone Transdermal System Drug: placebo patch	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Study to Evaluate the Efficacy and Safety of Transdermal Testosterone in Women With Hypoactive Sexual Desire Disorder on Concurrent Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	533
Study Start Date:	June 2002
Study Completion Date:	July 2006
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Placebo placebo patch for 6 months	Drug: placebo patch placebo patch replaced every 3-4 days for 6 months
Experimental: Testosterone Testosterone patch	Drug: Testosterone Transdermal System testosterone patch (300 mcg/day), patch changed twice a week for six months

Detailed Description:

Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. 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. Patients who completed the first 24 weeks of the study were given the opportunity to participate in a 3.5 year open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 at 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331214

Locations

United States, Colorado
Research Site
Denver, Colorado, United States
Australia, Queensland
Research Site
Nedlands, Queensland, Australia
Canada, Ontario
Research Site
Kingston, Ontario, Canada

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Johna Lucas, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Johna Lucas, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00331214 History of Changes
Other Study ID Numbers:	2001134 and Yr 2-4 OL
Study First Received:	May 26, 2006
Last Updated:	January 13, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Warner Chilcott:

Surgical menopause
HSDD

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate

Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012