Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
NCT ID: NCT00657501
Last Updated: 2013-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
575 participants
INTERVENTIONAL
2008-03-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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testosterone gel
1% testosterone transdermal gel
testosterone gel
once daily transdermal gel, 300 mcg
Placebo gel
placebo transdermal gel
placebo gel
once daily transdermal placebo gel
Interventions
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testosterone gel
once daily transdermal gel, 300 mcg
placebo gel
once daily transdermal placebo gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have undergone hysterectomy and bilateral salpingo-oophorectomy
Exclusion Criteria
* 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.
30 Years
65 Years
FEMALE
No
Sponsors
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BioSante Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Michael C Snabes, MD, PhD
Role: STUDY_DIRECTOR
BioSante Pharmaceuticals, Inc.
Locations
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BioSante Site #162
Sacramento, California, United States
BioSante Site #112
San Diego, California, United States
BioSante Site #159
Walnut Creek, California, United States
BioSante Site #026
Lakewood, Colorado, United States
BioSante Site #166
Farmington, Connecticut, United States
BioSante Site #146
Mobile, Alabama, United States
BioSante Site #171
Chandler, Arizona, United States
BioSante Site #145
Glendale, Arizona, United States
BioSante Site #121
Phoenix, Arizona, United States
BioSante Site #137
Tucson, Arizona, United States
BioSante Site #100
Jonesboro, Arkansas, United States
BioSante Site #155
Little Rock, Arkansas, United States
BioSante Site #221
Berkely, California, United States
BioSante Site #132
New Britain, Connecticut, United States
BioSante Site #151
New London, Connecticut, United States
BioSante Site #143
Jacksonville, Florida, United States
BioSante Site #111
Orlando, Florida, United States
BioSante Site #152
Tampa, Florida, United States
BioSante Site #115
Atlanta, Georgia, United States
BioSante Site #141
Roswell, Georgia, United States
BioSante Site #202
Idaho Falls, Idaho, United States
BioSante Site #017
Meridian, Idaho, United States
BioSante Site #156
Champaign, Illinois, United States
BioSante Site #045
Chicago, Illinois, United States
BioSante Site #149
Chicago, Illinois, United States
BioSante Site #133
Chicago, Illinois, United States
BioSante Site #167
Newburgh, Indiana, United States
BioSante Site #163
Overland Park, Kansas, United States
BioSante Site #214
Lexington, Kentucky, United States
BioSante Site #136
Lexington, Kentucky, United States
BioSante Site #157
Mandeville, Louisiana, United States
BioSante Site #110
Metarie, Louisiana, United States
BioSante Site #035
Ann Arbor, Michigan, United States
BioSante Site #124
Bingham Farms, Michigan, United States
BioSante Site #105
Kalamazoo, Michigan, United States
BioSante Site #104
St Louis, Missouri, United States
BioSante Site #127
Billings, Montana, United States
BioSante Site #114
Las Vegas, Nevada, United States
BioSante Site #161
Purchase, New York, United States
BioSante Site #107
Raleigh, North Carolina, United States
BioSante Site #131
Winston-Salem, North Carolina, United States
BioSante Site #130
Beachwood, Ohio, United States
BioSante Site #101
Cleveland, Ohio, United States
BioSante Site #160
Englewood, Ohio, United States
BioSante Site #153
Gallipolis, Ohio, United States
Site #170
Kettering, Ohio, United States
BioSante Site #116
Mayfield Heights, Ohio, United States
BioSante Site #138
West Chester, Ohio, United States
BioSante Site #129
Tulsa, Oklahoma, United States
BioSante Site #106
Eugene, Oregon, United States
BioSante Site #126
Medford, Oregon, United States
BioSante Site #203
Portland, Oregon, United States
BioSante Site #165
Jenkintown, Pennsylvania, United States
BioSante Site #142
Pittsburgh, Pennsylvania, United States
BioSante Site #099
Sellersville, Pennsylvania, United States
BioSante Site #075
Warwick, Rhode Island, United States
BioSante Site #117
Anderson, South Carolina, United States
BioSante Site #120
North Jackson, Tennessee, United States
BioSante Site #147
Dallas, Texas, United States
BioSante Site #122
Houston, Texas, United States
BioSante Site #154
Hurst, Texas, United States
BioSante Site #084
San Antonio, Texas, United States
BioSante Site #144
Pleasant Grove, Utah, United States
BioSante Site #102
Salt Lake City, Utah, United States
BioSante Site #128
Seattle, Washington, United States
BioSante Site #183
Walla Walla, Washington, United States
BioSante Site #175
Vancouver, British Columbia, Canada
BioSante Site #123
Ottawa, Ontario, Canada
BioSante Site #109
Québec, Quebec, Canada
Countries
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Related Links
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Bloomstudy.com
Other Identifiers
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TESTW008
Identifier Type: -
Identifier Source: org_study_id
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