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

NCT ID: NCT00331123

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 562 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• 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 surgically menopausal women who are taking estrogen therapy.

Detailed 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.

Conditions

Hypoactive Sexual Desire Disorder

Study Design

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

Study Groups

Placebo

Placebo patch

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo patch,changed every 3-4 days for 24 weeks during double blind phase

Testosterone Patch

Group Type: EXPERIMENTAL

Testosterone Transdermal System

Intervention Type: DRUG

testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks

Interventions

Testosterone Transdermal System

testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks

Intervention Type: DRUG

Placebo

placebo patch,changed every 3-4 days for 24 weeks during double blind phase

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Eligible women must:

1. Be 20-70 years old and in generally good health

2. Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening

3. Be receiving a stable dose of estrogen 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 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 P&GP study 1999068 or 1999092

10. Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

• Minimum Eligible Age: 20 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 Lucus, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

Research Site

Kansas City, Missouri, United States

Research Site

Prahran, Victoria, Australia

Research Site

Québec, Quebec, Canada

Countries

United States; Australia; Canada

Other Identifiers

2001133 and Yr 2-4 OL

Identifier Type: -

Identifier Source: org_study_id