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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| testosterone gel | Experimental | 1% testosterone transdermal gel |
|
| Placebo gel | Placebo Comparator | placebo transdermal gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| testosterone gel | Drug | once daily transdermal gel, 300 mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline over time for multiple efficacy measurements | change over timepoints from baseline period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Snabes, MD, PhD | BioSante Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSante Site #146 | Mobile | Alabama | 36608 | United States | ||
| BioSante Site #171 |
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| Label | URL |
|---|---|
| Bloomstudy.com | View source |
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| placebo gel | Drug | once daily transdermal placebo gel |
|
| Chandler |
| Arizona |
| 85224 |
| United States |
| BioSante Site #145 | Glendale | Arizona | 85306 | United States |
| BioSante Site #121 | Phoenix | Arizona | 85015 | United States |
| BioSante Site #137 | Tucson | Arizona | 85710 | United States |
| BioSante Site #100 | Jonesboro | Arkansas | 72401 | United States |
| BioSante Site #155 | Little Rock | Arkansas | 72223 | United States |
| BioSante Site #221 | Berkely | California | 94705 | United States |
| BioSante Site #162 | Sacramento | California | 95821 | United States |
| BioSante Site #112 | San Diego | California | 92103 | United States |
| BioSante Site #159 | Walnut Creek | California | 94598 | United States |
| BioSante Site #026 | Lakewood | Colorado | 80228 | United States |
| BioSante Site #166 | Farmington | Connecticut | 06032 | United States |
| BioSante Site #132 | New Britain | Connecticut | 06050 | United States |
| BioSante Site #151 | New London | Connecticut | 06320 | United States |
| BioSante Site #143 | Jacksonville | Florida | 32216 | United States |
| BioSante Site #111 | Orlando | Florida | 32806 | United States |
| BioSante Site #152 | Tampa | Florida | 33613 | United States |
| BioSante Site #115 | Atlanta | Georgia | 30342 | United States |
| BioSante Site #141 | Roswell | Georgia | 30075 | United States |
| BioSante Site #202 | Idaho Falls | Idaho | 83404 | United States |
| BioSante Site #017 | Meridian | Idaho | 83642 | United States |
| BioSante Site #156 | Champaign | Illinois | 61820 | United States |
| BioSante Site #045 | Chicago | Illinois | 60611 | United States |
| BioSante Site #149 | Chicago | Illinois | 60612 | United States |
| BioSante Site #133 | Chicago | Illinois | 60654 | United States |
| BioSante Site #167 | Newburgh | Indiana | 47630 | United States |
| BioSante Site #163 | Overland Park | Kansas | 66202 | United States |
| BioSante Site #214 | Lexington | Kentucky | 40504 | United States |
| BioSante Site #136 | Lexington | Kentucky | 40536 | United States |
| BioSante Site #157 | Mandeville | Louisiana | 70471 | United States |
| BioSante Site #110 | Metarie | Louisiana | 70006 | United States |
| BioSante Site #035 | Ann Arbor | Michigan | 48106 | United States |
| BioSante Site #124 | Bingham Farms | Michigan | 48025 | United States |
| BioSante Site #105 | Kalamazoo | Michigan | 49009 | United States |
| BioSante Site #104 | St Louis | Missouri | 63141 | United States |
| BioSante Site #127 | Billings | Montana | 59101 | United States |
| BioSante Site #114 | Las Vegas | Nevada | 89148 | United States |
| BioSante Site #161 | Purchase | New York | 10577 | United States |
| BioSante Site #107 | Raleigh | North Carolina | 27612 | United States |
| BioSante Site #131 | Winston-Salem | North Carolina | 27103 | United States |
| BioSante Site #130 | Beachwood | Ohio | 44122 | United States |
| BioSante Site #101 | Cleveland | Ohio | 44122 | United States |
| BioSante Site #160 | Englewood | Ohio | 45322 | United States |
| BioSante Site #153 | Gallipolis | Ohio | 45631 | United States |
| Site #170 | Kettering | Ohio | 45429 | United States |
| BioSante Site #116 | Mayfield Heights | Ohio | 44124 | United States |
| BioSante Site #138 | West Chester | Ohio | 45069 | United States |
| BioSante Site #129 | Tulsa | Oklahoma | 74104 | United States |
| BioSante Site #106 | Eugene | Oregon | 97401 | United States |
| BioSante Site #126 | Medford | Oregon | 97504 | United States |
| BioSante Site #203 | Portland | Oregon | 97227 | United States |
| BioSante Site #165 | Jenkintown | Pennsylvania | 19046 | United States |
| BioSante Site #142 | Pittsburgh | Pennsylvania | 15206 | United States |
| BioSante Site #099 | Sellersville | Pennsylvania | 18960 | United States |
| BioSante Site #075 | Warwick | Rhode Island | 02886 | United States |
| BioSante Site #117 | Anderson | South Carolina | 29621 | United States |
| BioSante Site #120 | North Jackson | Tennessee | 38305 | United States |
| BioSante Site #147 | Dallas | Texas | 75234 | United States |
| BioSante Site #122 | Houston | Texas | 77054 | United States |
| BioSante Site #154 | Hurst | Texas | 76054 | United States |
| BioSante Site #084 | San Antonio | Texas | 78229 | United States |
| BioSante Site #144 | Pleasant Grove | Utah | 84062 | United States |
| BioSante Site #102 | Salt Lake City | Utah | 84117 | United States |
| BioSante Site #128 | Seattle | Washington | 98105 | United States |
| BioSante Site #183 | Walla Walla | Washington | 99362 | United States |
| BioSante Site #175 | Vancouver | British Columbia | V6H 3X8 | Canada |
| BioSante Site #123 | Ottawa | Ontario | K1H 7W9 | Canada |
| BioSante Site #109 | Québec | Quebec | G1S 2L6 | Canada |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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