Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
NCT ID: NCT00613002
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
597 participants
INTERVENTIONAL
2006-12-31
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 testosterone 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 testosterone 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 topical 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 #215
Birmingham, Alabama, United States
BioSante Site #095
Hoover, Alabama, United States
BioSante Site #014
Huntsville, Alabama, United States
BioSante Site #027
Glendale, Arizona, United States
BioSante Site #040
Tucson, Arizona, United States
BioSante Site #052
Hot Springs, Arkansas, United States
BioSante Site #182
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
BioSante Site #036
Ridgefield, Connecticut, United States
BioSante Site #013
Washington D.C., District of Columbia, United States
BioSante Site #024
Miami, Florida, United States
BioSante Site #219
Pinellas Park, Florida, United States
BioSante Site #041
St. Petersburg, Florida, United States
BioSante Site #009
West Palm Beach, Florida, United States
BioSante Site #189
Addison, Illinois, United States
BioSante Site #005
Shreveport, Louisiana, United States
BioSante Site #004
Baltimore, Maryland, United States
BioSante Site #044
Detroit, Michigan, United States
BioSante Site #047
Grand Rapids, Michigan, United States
BioSante Site #033
Saginaw, Michigan, United States
BioSante Site #031
Saint Clair Shores, Michigan, United States
BioSante Site #208
Edina, Minnesota, United States
BioSante Site #198
Saint Paul, Minnesota, United States
BioSante Site #051
Missoula, Montana, United States
BioSante Site #006
Lincoln, Nebraska, United States
BioSante Site #217
Las Vegas, Nevada, United States
BioSante Site #015
Poughkeepsie, New York, United States
BioSante Site #059
Cary, North Carolina, United States
BioSante Site #079
Charlotte, North Carolina, United States
BioSante Site #061
Winston-Salem, North Carolina, United States
BioSante Site #056
Fargo, North Dakota, United States
BioSante Site #210
Akron, Ohio, United States
BioSante Site #212
Cincinnati, Ohio, United States
BioSante Site #213
Columbus, Ohio, United States
BioSante Site #050
Eugene, Oregon, United States
BioSante Site #197
Wexford, Pennsylvania, United States
BioSante Site #089
Columbia, South Carolina, United States
BioSante Site #209
Greer, South Carolina, United States
BioSante Site #097
Hilton Head Island, South Carolina, United States
BioSante Site #038
Mt. Pleasant, South Carolina, United States
BioSante Site #049
Watertown, South Dakota, United States
BioSante Site #093
Bristol, Tennessee, United States
BioSante Site #069
Chattanooga, Tennessee, United States
BioSante Site #078
Memphis, Tennessee, United States
BioSante Site #042
Nashville, Tennessee, United States
BioSante Site #048
Austin, Texas, United States
BioSante Site #073
Corpus Christi, Texas, United States
BioSane Site #220
Dallas, Texas, United States
BioSante Site #039
Houston, Texas, United States
BioSante Site #211
San Antonio, Texas, United States
BioSante Site #218
Murray, Utah, United States
BioSante Site #096
Williston, Vermont, United States
BioSante Site #003
Charlottesville, Virginia, United States
BioSante Site #086
Norfolk, Virginia, United States
BioSante Site #053
Richmond, Virginia, United States
BioSante Site #090
Virginia Beach, Virginia, United States
BioSante Site #083
Mountlake Terrace, Washington, United States
BioSante Site #181
Tacoma, Washington, United States
BioSante Site #188
Sarnia, Ontario, Canada
BioSante Site #054
Windsor, Ontario, Canada
BioSante Site #193
Shawinigan, Quebec, Canada
Countries
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Related Links
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http://www.bloomstudy.com
Other Identifiers
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TESTW006
Identifier Type: -
Identifier Source: org_study_id
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