Safety and Efficacy of LibiGel® for 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: NCT00657501

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: 575

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 transdermal 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.	Time Frame: 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 period

Trial Locations

Locations (69): BioSante Site #175
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Vancouver, British Columbia, Canada
BioSante Site #045
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Chicago, Illinois, United States
BioSante Site #149
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Chicago, Illinois, United States
BioSante Site #133
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Chicago, Illinois, United States
BioSante Site #101
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Cleveland, Ohio, United States
BioSante Site #114
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Las Vegas, Nevada, United States
BioSante Site #121
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Phoenix, Arizona, United States
BioSante Site #203
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Portland, Oregon, United States
BioSante Site #122
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Houston, Texas, United States
BioSante Site #128
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Seattle, Washington, United States
BioSante Site #084
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San Antonio, Texas, United States
BioSante Site #102
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Salt Lake City, Utah, United States
BioSante Site #154
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Hurst, Texas, United States
BioSante Site #144
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Pleasant Grove, Utah, United States
BioSante Site #109
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Quebec City, Quebec, Canada
BioSante Site #123
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Ottawa, Ontario, Canada
BioSante Site #183
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Walla Walla, Washington, United States
BioSante Site #171
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Chandler, Arizona, United States
BioSante Site #145
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Glendale, Arizona, United States
BioSante Site #146
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Mobile, Alabama, United States
BioSante Site #137
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Tucson, Arizona, United States
BioSante Site #100
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Jonesboro, Arkansas, United States
BioSante Site #155
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Little Rock, Arkansas, United States
BioSante Site #221
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Berkely, California, United States
BioSante Site #166
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Farmington, Connecticut, United States
BioSante Site #132
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New Britain, Connecticut, United States
BioSante Site #112
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San Diego, California, United States
BioSante Site #162
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Sacramento, California, United States
BioSante Site #159
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Walnut Creek, California, United States
BioSante Site #026
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Lakewood, Colorado, United States
BioSante Site #151
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New London, Connecticut, United States
BioSante Site #111
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Orlando, Florida, United States
BioSante Site #143
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Jacksonville, Florida, United States
BioSante Site #115
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Atlanta, Georgia, United States
BioSante Site #152
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Tampa, Florida, United States
BioSante Site #017
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Meridian, Idaho, United States
BioSante Site #202
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Idaho Falls, Idaho, United States
BioSante Site #141
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Roswell, Georgia, United States
BioSante Site #156
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Champaign, Illinois, United States
BioSante Site #163
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Overland Park, Kansas, United States
BioSante Site #167
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Newburgh, Indiana, United States
BioSante Site #157
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Mandeville, Louisiana, United States
BioSante Site #214
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Lexington, Kentucky, United States
BioSante Site #136
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Lexington, Kentucky, United States
BioSante Site #035
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Ann Arbor, Michigan, United States
BioSante Site #110
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Metarie, Louisiana, United States
BioSante Site #124
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Bingham Farms, Michigan, United States
BioSante Site #127
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Billings, Montana, United States
BioSante Site #105
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Kalamazoo, Michigan, United States
BioSante Site #104
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St. Louis, Missouri, United States
BioSante Site #161
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Purchase, New York, United States
BioSante Site #107
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Raleigh, North Carolina, United States
BioSante Site #131
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Winston Salem, North Carolina, United States
BioSante Site #130
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Beachwood, Ohio, United States
Site #170
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Kettering, Ohio, United States
BioSante Site #129
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Tulsa, Oklahoma, United States
BioSante Site #153
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Gallipolis, Ohio, United States
BioSante Site #160
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Englewood, Ohio, United States
BioSante Site #138
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West Chester, Ohio, United States
BioSante Site #116
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Mayfield Heights, Ohio, United States
BioSante Site #142
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Pittsburgh, Pennsylvania, United States
BioSante Site #099
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Sellersville, Pennsylvania, United States
BioSante Site #165
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Jenkintown, Pennsylvania, United States
BioSante Site #106
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Eugene, Oregon, United States
BioSante Site #117
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Anderson, South Carolina, United States
BioSante Site #075
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Warwick, Rhode Island, United States
BioSante Site #147
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Dallas, Texas, United States
BioSante Site #120
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North Jackson, Tennessee, United States
BioSante Site #126
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Medford, Oregon, United States