This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
Detailed Description: Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
814
Testosterone patch (300mcg/day, changed twice a week for one year
placebo patch changed twice a week for one year
Monash Medical School, The Alfred Hospital
Prahran, Victoria, Australia
Total satisfying sexual activity over 24 weeks
Time frame: 6, 12, 24, 36, and 52 weeks
Sexual desire
Time frame: 6, 12, 24, 36, and 52 weeks
personal distress
Time frame: 6, 12, 24, 36, and 52 weeks
other domains of the Profile of Female Sexual Function over 24 weeks
Time frame: 6, 12, 24, 36, and 52 weeks
mood, energy and well-being
Time frame: 6, 12, 24, 36, and 52 weeks
menopausal symptoms
Time frame: 6, 12, 24, 36, and 52 weeks
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