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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Drug: Placebo patch; Drug: Testosterone Transdermal System

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 Type: Interventional
• Enrollment (Actual): 610
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80202
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Eligible women must:

1. Be 40-70 years old and in generally good health
2. Be post-menopausal with no spontaneous periods for 1 year
3. Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
4. 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
5. Meet the criteria for having hypoactive sexual desire disorder

Exclusion Criteria:

Eligible women must not:

1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
7. 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
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Warner Chilcott

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: June 15, 2006
• First Submitted That Met QC Criteria: June 15, 2006
• First Posted (Estimate): June 20, 2006

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HSDD; Natural Menopause
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia; Sexual Dysfunctions, Psychological; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 2002005 and Yr 2-4 OL