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

Last updated: April 15, 2013
Sponsor: Warner Chilcott
Overall Status: Completed

Phase

3

Condition

Sexual Dysfunction

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT00338312
2002005 and Yr 2-4 OL
  • Ages 40-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 priorto screening with the intention of maintaining that regimen.

  4. Be, in her own judgment, in a stable, monogamous sexual relationship that is perceivedto be secure and communicative, for at least one year prior to study entry

  5. Meet the criteria for having hypoactive sexual desire disorder

Exclusion

Exclusion Criteria: Eligible women must not:

  1. Have received androgen therapy at any time during the past 3 months (during the past 7months 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 toadhesives (like the ones in bandages)

  5. Have had a major illness, active gall bladder disease, or gynecological or breastsurgery within the last 6 months

  6. Have a history of breast, endometrial, or other gynecological cancer at any timebefore study participation or other cancer within the last 5 years

  7. Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heartattack, or angina at any time before study participation or thrombophlebitis withinthe 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 aninvestigational medication within 30 days

Study Design

Total Participants: 610
Study Start date:
June 01, 2002
Estimated Completion Date:
July 31, 2006

Study 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.

Connect with a study center

  • Research Facility

    Denver, Colorado 80202
    United States

    Site Not Available

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