Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido
Hypoactive Sexual Desire Disorder
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring Natural Menopause, HSDD
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Research Facility
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
1
2
Placebo patch
testosterone patch (300 mcg/day) patch changed 2 times/week, for one year