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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoactive Sexual Desire Disorder (HSDD)

In brief

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.

Key facts

Study ID

NCT00349791

Run by

Warner Chilcott

People needed

549

Starts

2002-06-01

Expected to finish

2003-10-01

Last updated by the study team

2013-04-17

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 pror 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

You may not qualify if…

• 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, thrombo-embolic 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

Where it is running

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

Full record on ClinicalTrials.gov

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