Study of Transdermal Testosterone Patches in Surgically 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

NCT00331123
2001133 and Yr 2-4 OL
  • Ages 20-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 toscreening

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

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

Study Design

Total Participants: 562
Study Start date:
May 01, 2002
Estimated Completion Date:
July 31, 2006

Study 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.

Connect with a study center

  • Research Site

    Prahran, Victoria
    Australia

    Site Not Available

  • Research Site

    Quebec,
    Canada

    Site Not Available

  • Research Site

    Kansas City, Missouri
    United States

    Site Not Available

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