Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Phase 3

Completed

Conditions: Hypoactive Sexual Desire Disorder

Interventions: Drug: testosterone gel
Drug: placebo gel

Registration Number: NCT00613002

Lead Sponsor: BioSante Pharmaceuticals

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 597

Inclusion Criteria

Must be between the ages of 30 to 65 years
Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion Criteria

A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
Any systemic skin diseases or local skin abnormalities in the area of application
Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
A medical condition that could affect or interfere with sexual function
Using a systemic topical gel or cream estrogen therapy.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone gel	testosterone gel	1% testosterone transdermal gel
placebo gel	placebo gel	placebo transdermal gel

Primary Outcome Measures

Name	Time	Method
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.	Baseline and 21-24 weeks.

Secondary Outcome Measures

Name	Time	Method
Change from baseline over time for multiple efficacy measurements	change over timepoints from baseline

Trial Locations

Locations (63): BioSante Site #040
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Tucson, Arizona, United States
BioSante Site #209
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Greer, South Carolina, United States
BioSante Site #097
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Hilton Head Island, South Carolina, United States
BioSante Site #078
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Memphis, Tennessee, United States
BioSante Site #052
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Hot Springs, Arkansas, United States
BioSante Site #050
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Eugene, Oregon, United States
BioSante Site #089
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Columbia, South Carolina, United States
BioSante Site #197
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Wexford, Pennsylvania, United States
BioSante Site #049
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Watertown, South Dakota, United States
BioSante Site #093
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Bristol, Tennessee, United States
BioSante Site #041
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St. Petersburg, Florida, United States
BioSante Site #004
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Baltimore, Maryland, United States
BioSante Site #059
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Cary, North Carolina, United States
BioSante Site #213
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Columbus, Ohio, United States
BioSane Site #220
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Dallas, Texas, United States
BioSante Site #090
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Virginia Beach, Virginia, United States
BioSante Site #024
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Miami, Florida, United States
BioSante Site #039
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Houston, Texas, United States
BioSante Site #008
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San Diego, California, United States
BioSante Site #217
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Las Vegas, Nevada, United States
BioSante Site #211
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San Antonio, Texas, United States
BioSante Site #212
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Cincinnati, Ohio, United States
BioSante Site #042
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Nashville, Tennessee, United States
BioSante Site #056
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Fargo, North Dakota, United States
BioSante Site #044
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Detroit, Michigan, United States
BioSante Site #215
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Birmingham, Alabama, United States
BioSante Site #095
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Hoover, Alabama, United States
BioSante Site #014
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Huntsville, Alabama, United States
BioSante Site #027
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Glendale, Arizona, United States
BioSante Site #182
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Buena Park, California, United States
BioSante Site #216
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Denver, Colorado, United States
BioSante Site #036
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Ridgefield, Connecticut, United States
BioSante Site #013
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Washington, District of Columbia, United States
BioSante Site #007
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Denver, Colorado, United States
BioSante Site #009
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West Palm Beach, Florida, United States
BioSante Site #219
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Pinellas Park, Florida, United States
BioSante Site #189
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Addison, Illinois, United States
BioSante Site #047
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Grand Rapids, Michigan, United States
BioSante Site #031
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St. Clair Shores, Michigan, United States
BioSante Site #033
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Saginaw, Michigan, United States
BioSante Site #051
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Missoula, Montana, United States
BioSante Site #208
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Edina, Minnesota, United States
BioSante Site #198
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St. Paul, Minnesota, United States
BioSante Site #006
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Lincoln, Nebraska, United States
BioSante Site #079
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Charlotte, North Carolina, United States
BioSante Site #015
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Poughkeepsie, New York, United States
BioSante Site #061
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Winston-Salem, North Carolina, United States
BioSante Site #210
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Akron, Ohio, United States
BioSante Site #038
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Mount Pleasant, South Carolina, United States
BioSante Site #069
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Chattanooga, Tennessee, United States
BioSante Site #048
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Austin, Texas, United States
BioSante Site #073
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Corpus Christi, Texas, United States
BioSante Site #218
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Murray, Utah, United States
BioSante Site #086
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Norfolk, Virginia, United States
BioSante Site #003
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Charlottesville, Virginia, United States
BioSante Site #096
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Williston, Vermont, United States
BioSante Site #053
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Richmond, Virginia, United States
BioSante Site #054
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Windsor, Ontario, Canada
BioSante Site #083
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Mountlake Terrace, Washington, United States
BioSante Site #181
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Tacoma, Washington, United States
BioSante Site #188
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Sarnia, Ontario, Canada
BioSante Site #193
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Shawinigan, Quebec, Canada
BioSante Site #005
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Shreveport, Louisiana, United States