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

NCT ID: NCT00338312

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2006-07-31

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.

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.

Conditions

Hypoactive Sexual Desire Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo patch

Group Type: PLACEBO_COMPARATOR

Placebo patch

Intervention Type: DRUG

placebo patch changed twice a week for one year

2

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

Group Type: EXPERIMENTAL

Testosterone Transdermal System

Intervention Type: DRUG

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

Interventions

Testosterone Transdermal System

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

Intervention Type: DRUG

Placebo patch

placebo patch changed twice a week for one year

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Warner Chilcott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johna Lucas, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Research Facility

Denver, Colorado, United States

Countries

United States

Other Identifiers

2002005 and Yr 2-4 OL

Identifier Type: -

Identifier Source: org_study_id