Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

April 15, 2013 updated by: Warner Chilcott

A Study to Evaluate the Efficacy/Safety of Transdermal Testosterone for 24 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

Detailed Description

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were randomized to receive a placebo or testosterone transdermal system throughout the study. 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.

Study Type

Interventional

Enrollment (Actual)

549

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Randwick, Australia
        • Research Facility
      • Quebec, Canada
        • Research Facility
    • Illinois
      • Chicago, Illinois, United States
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 pror 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, thrombo-embolic 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
placebo patch replaced twice a week for two years
placebo patch replaced twice a week for two years
Experimental: 2
testosterone patch replaced twice a week for two years
testosterone (300 mcg/day) patch replaced twice a week for two years

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).
Time Frame: 2 years
2 years

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.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

July 7, 2006

First Submitted That Met QC Criteria

July 7, 2006

First Posted (Estimate)

July 10, 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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