Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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