Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
Study to Evaluate Efficacy and Safety of Transdermal Testosterone and Safety for an Open-label Period in Women With Hypoactive Sexual Desire Disorder on Estrogen Replacement Therapy and Undergone Hysterectomy/Bilateral Oophorectomy.
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.
Status | Completed |
Enrollment | 562 |
Est. completion date | July 2006 |
Est. primary completion date | December 2003 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility |
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 to screening 3. Be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen. 4. 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. 5. Meet the criteria for having hypoactive sexual desire disorder. Exclusion Criteria: Eligible women must not: 1. Have received androgen therapy at any time during the past 3 months (during the past 7 months 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 to adhesives (like the ones in bandages) 5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months 6. Have a history of breast, endometrial, or other gynecological cancer any time before study participation or other cancer within the last 5 years 7. 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 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 an investigation medication within 30 days. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Prahran | Victoria |
Canada | Research Site | Quebec | |
United States | Research Site | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Warner Chilcott |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the efficacy of testosterone transdermal system (TTS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL). | 24 weeks | No | |
Secondary | To assess the efficacy measured by the change from baseline in sexual desire; personal distress as measured by the Personal Distress Scale score; the other 6 domains of the profile of Female Sexual Function; and the other 8 SAL endpoints. | 24 weeks | No |
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