Status:
COMPLETED
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Lead Sponsor:
Warner Chilcott
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
40-70 years
Phase:
PHASE3
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 stratif...
Eligibility Criteria
Inclusion
- Eligible women must:
- Be 40-70 years old and in generally good health
- Be post-menopausal with no spontaneous periods for 1 year
- Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
- 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
- Meet the criteria for having hypoactive sexual desire disorder
Exclusion
- Eligible women must not:
- Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
- Be experiencing any chronic or acute life stress relating to any major life change
- Be experiencing depression and/or receiving medication for such illness or disorder
- Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
- Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
- Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
- 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
- Have abnormal laboratory test results upon initial screening for this study
- Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT00338312
Start Date
June 1 2002
End Date
July 1 2006
Last Update
April 17 2013
Active Locations (1)
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1
Research Facility
Denver, Colorado, United States, 80202