Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
| Status | Completed |
| Enrollment | 626 |
| Est. completion date | January 2012 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years to 66 Years |
| Eligibility |
Inclusion Criteria: - must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial Exclusion Criteria: - Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | BioSante Site# 123 | Ottawa | Ontario |
| Canada | BioSante Site #188 | Sarnia | Ontario |
| Canada | BioSante Site #193 | Shawinigan | Quebec |
| Canada | BioSante Site #054 | Windsor | Ontario |
| United States | BioSante Site #189 | Addison | Illinois |
| United States | BioSante Site #210 | Akron | Ohio |
| 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 #048 | Austin | Texas |
| United States | BioSante Site #130 | Beachwood | Ohio |
| United States | BioSante Site #221 | Berkeley | California |
| United States | BioSante Site #127 | Billings | Montana |
| United States | BioSante Site #124 | Bingham Farms | Michigan |
| United States | BioSante Site #182 | Buena Park | California |
| United States | BioSante Site #059 | Cary | North Carolina |
| United States | BioSante Site #171 | Chandler | Arizona |
| United States | BioSante Site #003 | Charlottesville | Virginia |
| United States | BioSante Site #069 | Chattanooga | Tennessee |
| United States | BioSante Site #133 | Chicago | Illinois |
| United States | BioSante Site #212 | Cincinnati | Ohio |
| United States | BioSante Site #101 | Cleveland | Ohio |
| United States | BioSante Site #089 | Columbia | South Carolina |
| United States | BioSante Site #213 | Columbus | Ohio |
| United States | BioSante Site #073 | Corpus Christi | Texas |
| United States | BioSante Site #147 | Dallas | Texas |
| United States | BioSante Site #220 | Dallas | Texas |
| United States | BioSante Site #007 | Denver | Colorado |
| United States | BioSante Site #044 | Detroit | Michigan |
| United States | BioSante Site #208 | Edina | Minnesota |
| United States | BioSante Site #160 | Englewood | Ohio |
| United States | BioSante Site #050 | Eugene | Oregon |
| United States | BioSante Site #106 | Eugene | Oregon |
| United States | BioSante Site #206 | Fall River | Massachusetts |
| United States | BioSante Site #056 | Fargo | North Dakota |
| United States | BioSante Site #153 | Gallipolis | Ohio |
| United States | BioSante Site #027 | Glendale | Arizona |
| United States | BioSante Site #145 | Glendale | Arizona |
| United States | BioSante Site #047 | Grand Rapids | Michigan |
| United States | BioSante Site #209 | Greer | South Carolina |
| United States | BioSante Site #095 | Hoover | Alabama |
| United States | BioSante Site #052 | Hot Springs | Arkansas |
| United States | BioSante Site #039 | Houston | Texas |
| United States | BioSante Site #122 | Houston | Texas |
| United States | BioSante Site #014 | Huntsville | Alabama |
| 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 #105 | Kalamazoo | Michigan |
| United States | BioSante Site #026 | Lakewood | Colorado |
| United States | BioSante Site #214 | Lexington | Kentucky |
| United States | BioSante Site #006 | Lincoln | Nebraska |
| United States | BioSante Site #155 | Little Rock | Arkansas |
| United States | BioSante Site #126 | Medford | Oregon |
| United States | BioSante Site #078 | Memphis | Tennessee |
| United States | BioSante Site #017 | Meridian | Idaho |
| United States | BioSante Site #110 | Metarie | Louisiana |
| United States | BioSante Site #024 | Miami | Florida |
| United States | BioSante Site #051 | Missoula | Montana |
| United States | BioSante Site #146 | Mobile | Alabama |
| United States | BioSante Site #083 | Mountlake Terrace | Washington |
| United States | BioSante Site #218 | Murray | Utah |
| United States | BioSante Site #042 | Nashville | Tennessee |
| 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 #086 | Norfolk | Virginia |
| 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 #219 | Pinellas Park | Florida |
| United States | BioSante Site #144 | Pleasant Grove | Utah |
| United States | BioSante Site #015 | Poughkeepsie | New York |
| United States | BioSante Site #107 | Raleigh | North Carolina |
| United States | BioSante Site #053 | Richmond | Virginia |
| United States | BioSante Site #036 | Ridgefield | Connecticut |
| United States | BioSante Site #141 | Roswell | Georgia |
| United States | BioSante Site #162 | Sacramento | California |
| United States | BioSante Site #033 | Saginaw | Michigan |
| United States | BioSante Site #102 | Salt Lake City | Utah |
| United States | BioSante Site #211 | San Antonio | Texas |
| United States | BioSante Site #008 | San Diego | California |
| United States | BioSante Site #128 | Seattle | Washington |
| United States | BioSante Site #099 | Sellersville | Pennsylvania |
| United States | BioSante Site #005 | Shreveport | Louisiana |
| United States | BioSante Site #031 | St. Clair Shores | Michigan |
| United States | BioSante Site #104 | St. Louis | Missouri |
| United States | BioSante Site #198 | St. Paul | Minnesota |
| United States | BioSante Site #041 | St. Petersburg | Florida |
| United States | BioSante Site #181 | Tacoma | Washington |
| 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 #049 | Watertown | South Dakota |
| United States | BioSante Site #138 | West Chester | Ohio |
| United States | BioSante Site #009 | West Palm Beach | Florida |
| United States | BioSante Site #197 | Wexford | Pennsylvania |
| United States | BioSante Site #096 | Williston | Vermont |
| 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 | Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study | This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. | 12 weeks | No |
| Secondary | change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study | This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. | 12 weeks | No |
| Secondary | change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study | This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. | 12 weeks | No |
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