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
597
once daily transdermal testosterone 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: Baseline and 21-24 weeks.
Change from baseline over time for multiple efficacy measurements
Time frame: change over timepoints from baseline
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BioSante Site #215
Birmingham, Alabama, United States
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Hoover, Alabama, United States
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Huntsville, Alabama, United States
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Glendale, Arizona, United States
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Tucson, Arizona, United States
BioSante Site #052
Hot Springs, Arkansas, United States
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Buena Park, California, United States
BioSante Site #008
San Diego, California, United States
BioSante Site #007
Denver, Colorado, United States
BioSante Site #216
Denver, Colorado, United States
...and 53 more locations