Status:
COMPLETED
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Lead Sponsor:
Warner Chilcott
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
20-70 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.
Detailed Description
Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (DB), pa...
Eligibility Criteria
Inclusion
- Eligible women must:
- Be 20-70 years old and in generally good health
- Have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening
- Be receiving a stable dose of estrogen 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 P\&GP study 1999068 or 1999092
- Have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT00331214
Start Date
June 1 2002
End Date
July 1 2006
Last Update
April 17 2013
Active Locations (3)
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1
Research Site
Denver, Colorado, United States
2
Research Site
Nedlands, Queensland, Australia
3
Research Site
Kingston, Ontario, Canada