Hypoactive Sexual Desire Disorder Clinical Trial
— BLOOMOfficial title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
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.
Status | Completed |
Enrollment | 575 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | BioSante Site #123 | Ottawa | Ontario |
Canada | BioSante Site #109 | Quebec City | Quebec |
Canada | BioSante Site #175 | Vancouver | British Columbia |
United States | BioSante Site #117 | Anderson | South Carolina |
United States | BioSante Site #035 | Ann Arbor | Michigan |
United States | BioSante Site #115 | Atlanta | Georgia |
United States | BioSante Site #130 | Beachwood | Ohio |
United States | BioSante Site #221 | Berkely | California |
United States | BioSante Site #127 | Billings | Montana |
United States | BioSante Site #124 | Bingham Farms | Michigan |
United States | BioSante Site #156 | Champaign | Illinois |
United States | BioSante Site #171 | Chandler | Arizona |
United States | BioSante Site #045 | Chicago | Illinois |
United States | BioSante Site #133 | Chicago | Illinois |
United States | BioSante Site #149 | Chicago | Illinois |
United States | BioSante Site #101 | Cleveland | Ohio |
United States | BioSante Site #147 | Dallas | Texas |
United States | BioSante Site #160 | Englewood | Ohio |
United States | BioSante Site #106 | Eugene | Oregon |
United States | BioSante Site #166 | Farmington | Connecticut |
United States | BioSante Site #153 | Gallipolis | Ohio |
United States | BioSante Site #145 | Glendale | Arizona |
United States | BioSante Site #122 | Houston | Texas |
United States | BioSante Site #154 | Hurst | Texas |
United States | BioSante Site #202 | Idaho Falls | Idaho |
United States | BioSante Site #143 | Jacksonville | Florida |
United States | BioSante Site #165 | Jenkintown | Pennsylvania |
United States | BioSante Site #100 | Jonesboro | Arkansas |
United States | BioSante Site #105 | Kalamazoo | Michigan |
United States | Site #170 | Kettering | Ohio |
United States | BioSante Site #026 | Lakewood | Colorado |
United States | BioSante Site #114 | Las Vegas | Nevada |
United States | BioSante Site #136 | Lexington | Kentucky |
United States | BioSante Site #214 | Lexington | Kentucky |
United States | BioSante Site #155 | Little Rock | Arkansas |
United States | BioSante Site #157 | Mandeville | Louisiana |
United States | BioSante Site #116 | Mayfield Heights | Ohio |
United States | BioSante Site #126 | Medford | Oregon |
United States | BioSante Site #017 | Meridian | Idaho |
United States | BioSante Site #110 | Metarie | Louisiana |
United States | BioSante Site #146 | Mobile | Alabama |
United States | BioSante Site #132 | New Britain | Connecticut |
United States | BioSante Site #151 | New London | Connecticut |
United States | BioSante Site #167 | Newburgh | Indiana |
United States | BioSante Site #120 | North Jackson | Tennessee |
United States | BioSante Site #111 | Orlando | Florida |
United States | BioSante Site #163 | Overland Park | Kansas |
United States | BioSante Site #121 | Phoenix | Arizona |
United States | BioSante Site #142 | Pittsburgh | Pennsylvania |
United States | BioSante Site #144 | Pleasant Grove | Utah |
United States | BioSante Site #203 | Portland | Oregon |
United States | BioSante Site #161 | Purchase | New York |
United States | BioSante Site #107 | Raleigh | North Carolina |
United States | BioSante Site #141 | Roswell | Georgia |
United States | BioSante Site #162 | Sacramento | California |
United States | BioSante Site #102 | Salt Lake City | Utah |
United States | BioSante Site #084 | San Antonio | Texas |
United States | BioSante Site #112 | San Diego | California |
United States | BioSante Site #128 | Seattle | Washington |
United States | BioSante Site #099 | Sellersville | Pennsylvania |
United States | BioSante Site #104 | St. Louis | Missouri |
United States | BioSante Site #152 | Tampa | Florida |
United States | BioSante Site #137 | Tucson | Arizona |
United States | BioSante Site #129 | Tulsa | Oklahoma |
United States | BioSante Site #183 | Walla Walla | Washington |
United States | BioSante Site #159 | Walnut Creek | California |
United States | BioSante Site #075 | Warwick | Rhode Island |
United States | BioSante Site #138 | West Chester | Ohio |
United States | BioSante Site #131 | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
BioSante Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | Change from baseline over time for multiple efficacy measurements | change over timepoints from baseline period | No |
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