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.
Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 24-week, multicenter, multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were randomized to receive a placebo or testosterone transdermal system throughout the study. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. Physical exam including clinical assessments of facial hair and acne were monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
549
testosterone (300 mcg/day) patch replaced twice a week for two years
placebo patch replaced twice a week for two years
Research Facility
Chicago, Illinois, United States
Research Facility
Randwick, Australia
Research Facility
Québec, Quebec, Canada
To assess the efficacy of the 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).
Time frame: 2 years
To assess the efficacy measured by the change from baseline in sexual desire using personal distress as measured by the Personal Distress Scale (PDS) score; the other 6 domains of the Profile of Female Sexual function, and the other 8 SAL endpoints.
Time frame: 2 years
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