This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
575
once daily transdermal gel, 300 mcg
once daily transdermal placebo gel
Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.
Time frame: Time Frame: Baseline and 21-24 weeks.
Change from baseline over time for multiple efficacy measurements
Time frame: change over timepoints from baseline period
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BioSante Site #146
Mobile, Alabama, United States
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Berkely, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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