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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 testosterone 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. | Baseline and 21-24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline over time for multiple efficacy measurements | change over timepoints from baseline |
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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 #215 | Birmingham | Alabama | 35209 | United States | ||
| BioSante Site #095 |
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| Label | URL |
|---|---|
| http://www.bloomstudy.com | View source |
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| placebo gel | Drug | once daily transdermal placebo gel |
|
| Hoover |
| Alabama |
| 35216 |
| United States |
| BioSante Site #014 | Huntsville | Alabama | 35801 | United States |
| BioSante Site #027 | Glendale | Arizona | 85308 | United States |
| BioSante Site #040 | Tucson | Arizona | 85715 | United States |
| BioSante Site #052 | Hot Springs | Arkansas | 71913 | United States |
| BioSante Site #182 | Buena Park | California | 90620 | United States |
| BioSante Site #008 | San Diego | California | 92108 | United States |
| BioSante Site #007 | Denver | Colorado | 80218 | United States |
| BioSante Site #216 | Denver | Colorado | 80239 | United States |
| BioSante Site #036 | Ridgefield | Connecticut | 06877 | United States |
| BioSante Site #013 | Washington D.C. | District of Columbia | 20036 | United States |
| BioSante Site #024 | Miami | Florida | 33126 | United States |
| BioSante Site #219 | Pinellas Park | Florida | 33781 | United States |
| BioSante Site #041 | St. Petersburg | Florida | 33709 | United States |
| BioSante Site #009 | West Palm Beach | Florida | 33409 | United States |
| BioSante Site #189 | Addison | Illinois | 60101 | United States |
| BioSante Site #005 | Shreveport | Louisiana | 71115 | United States |
| BioSante Site #004 | Baltimore | Maryland | 21285 | United States |
| BioSante Site #044 | Detroit | Michigan | 48201 | United States |
| BioSante Site #047 | Grand Rapids | Michigan | 49503 | United States |
| BioSante Site #033 | Saginaw | Michigan | 48604 | United States |
| BioSante Site #031 | Saint Clair Shores | Michigan | 48081 | United States |
| BioSante Site #208 | Edina | Minnesota | 55435 | United States |
| BioSante Site #198 | Saint Paul | Minnesota | 55108 | United States |
| BioSante Site #051 | Missoula | Montana | 59808 | United States |
| BioSante Site #006 | Lincoln | Nebraska | 68501 | United States |
| BioSante Site #217 | Las Vegas | Nevada | 89146 | United States |
| BioSante Site #015 | Poughkeepsie | New York | 12601 | United States |
| BioSante Site #059 | Cary | North Carolina | 27518 | United States |
| BioSante Site #079 | Charlotte | North Carolina | 28209 | United States |
| BioSante Site #061 | Winston-Salem | North Carolina | 27103 | United States |
| BioSante Site #056 | Fargo | North Dakota | 58103 | United States |
| BioSante Site #210 | Akron | Ohio | 44311 | United States |
| BioSante Site #212 | Cincinnati | Ohio | 45249 | United States |
| BioSante Site #213 | Columbus | Ohio | 43212 | United States |
| BioSante Site #050 | Eugene | Oregon | 97401 | United States |
| BioSante Site #197 | Wexford | Pennsylvania | 15090 | United States |
| BioSante Site #089 | Columbia | South Carolina | 29201 | United States |
| BioSante Site #209 | Greer | South Carolina | 29651 | United States |
| BioSante Site #097 | Hilton Head Island | South Carolina | 29926 | United States |
| BioSante Site #038 | Mt. Pleasant | South Carolina | 29464 | United States |
| BioSante Site #049 | Watertown | South Dakota | 57201 | United States |
| BioSante Site #093 | Bristol | Tennessee | 37620 | United States |
| BioSante Site #069 | Chattanooga | Tennessee | 37404 | United States |
| BioSante Site #078 | Memphis | Tennessee | 38120 | United States |
| BioSante Site #042 | Nashville | Tennessee | 37203 | United States |
| BioSante Site #048 | Austin | Texas | 78705 | United States |
| BioSante Site #073 | Corpus Christi | Texas | 78414 | United States |
| BioSane Site #220 | Dallas | Texas | 75231 | United States |
| BioSante Site #039 | Houston | Texas | 77054 | United States |
| BioSante Site #211 | San Antonio | Texas | 78229 | United States |
| BioSante Site #218 | Murray | Utah | 84123 | United States |
| BioSante Site #096 | Williston | Vermont | 05495 | United States |
| BioSante Site #003 | Charlottesville | Virginia | 22903 | United States |
| BioSante Site #086 | Norfolk | Virginia | 23502 | United States |
| BioSante Site #053 | Richmond | Virginia | 23294 | United States |
| BioSante Site #090 | Virginia Beach | Virginia | 23456 | United States |
| BioSante Site #083 | Mountlake Terrace | Washington | 98043 | United States |
| BioSante Site #181 | Tacoma | Washington | 98405 | United States |
| BioSante Site #188 | Sarnia | Ontario | N7T 4X3 | Canada |
| BioSante Site #054 | Windsor | Ontario | N8W5L7 | Canada |
| BioSante Site #193 | Shawinigan | Quebec | G9N 2H6 | 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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