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

Sponsor

Warner Chilcott (Industry)

Overall Status

Completed

CT.gov ID

NCT00338312

Collaborator

(none)

610

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 therapy.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Testosterone Transdermal System Drug: Placebo patch	Phase 3

Detailed Description

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 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 metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.

Study Design

Study Type:

Interventional

Actual Enrollment :

610 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 52 Weeks and Safety for 52 Weeks in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder on Oral Hormone Replacement Therapy.

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo patch	Drug: Placebo patch placebo patch changed twice a week for one year
Experimental: 2 testosterone patch (300 mcg/day) patch changed 2 times/week, for one year	Drug: Testosterone Transdermal System testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

Arm

Intervention/Treatment

Placebo Comparator: 1

Placebo patch

Drug: Placebo patch

placebo patch changed twice a week for one year

Experimental: 2

testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

Drug: Testosterone Transdermal System

testosterone patch (300 mcg/day) patch changed 2 times/week, for one year

Outcome Measures

Primary Outcome Measures

To assess the efficacy of the transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). [12 months]

Secondary Outcome Measures

To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Eligible women must:

Be 40-70 years old and in generally good health
Be post-menopausal with no spontaneous periods for 1 year
Be receiving a stable dose of hormone 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 a clinical trial within 30 days or received an investigational medication within 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Facility	Denver	Colorado	United States	80202

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director: Johna Lucas, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Warner Chilcott

ClinicalTrials.gov Identifier:

NCT00338312

Other Study ID Numbers:

2002005 and Yr 2-4 OL

First Posted:

Jun 20, 2006

Last Update Posted:

Apr 17, 2013

Last Verified:

Apr 1, 2013

Keywords provided by Warner Chilcott

Natural Menopause

HSDD

Additional relevant MeSH terms:

Hypokinesia

Sexual Dysfunctions, Psychological

Testosterone

Study Results

No Results Posted as of Apr 17, 2013