Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Drug: placebo gel
- Registration Number
- NCT01235754
- Lead Sponsor
- BioSante Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 626
- must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo gel placebo gel placebo transdermal gel testosterone gel transdermal testosterone gel 1% transdermal testosterone gel
- Primary Outcome Measures
Name Time Method 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 12 weeks 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.
- Secondary Outcome Measures
Name Time Method change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study 12 weeks 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.
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 12 weeks 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.
Trial Locations
- Locations (102)
BioSante Site #101
🇺🇸Cleveland, Ohio, United States
BioSante Site #128
🇺🇸Seattle, Washington, United States
BioSante Site #024
🇺🇸Miami, Florida, United States
BioSante Site #122
🇺🇸Houston, Texas, United States
BioSante Site #008
🇺🇸San Diego, California, United States
BioSante Site #212
🇺🇸Cincinnati, Ohio, United States
BioSante Site #211
🇺🇸San Antonio, Texas, United States
BioSante Site #163
🇺🇸Overland Park, Kansas, United States
BioSante Site #121
🇺🇸Phoenix, Arizona, United States
BioSante Site #044
🇺🇸Detroit, Michigan, United States
BioSante Site #042
🇺🇸Nashville, Tennessee, United States
BioSante Site #102
🇺🇸Salt Lake City, Utah, United States
BioSante Site #146
🇺🇸Mobile, Alabama, United States
BioSante Site #095
🇺🇸Hoover, Alabama, United States
BioSante Site #086
🇺🇸Norfolk, Virginia, United States
BioSante Site #120
🇺🇸North Jackson, Tennessee, United States
BioSante Site #052
🇺🇸Hot Springs, Arkansas, United States
BioSante Site #096
🇺🇸Williston, Vermont, United States
BioSante Site #039
🇺🇸Houston, Texas, United States
BioSante Site #154
🇺🇸Hurst, Texas, United States
BioSante Site #053
🇺🇸Richmond, Virginia, United States
BioSante Site #183
🇺🇸Walla Walla, Washington, United States
BioSante Site #048
🇺🇸Austin, Texas, United States
BioSante Site #144
🇺🇸Pleasant Grove, Utah, United States
BioSante Site #003
🇺🇸Charlottesville, Virginia, United States
BioSante Site #073
🇺🇸Corpus Christi, Texas, United States
BioSante Site #083
🇺🇸Mountlake Terrace, Washington, United States
BioSante Site #220
🇺🇸Dallas, Texas, United States
BioSante Site #218
🇺🇸Murray, Utah, United States
BioSante Site #054
🇨🇦Windsor, Ontario, Canada
BioSante Site #007
🇺🇸Denver, Colorado, United States
BioSante Site #193
🇨🇦Shawinigan, Quebec, Canada
BioSante Site #145
🇺🇸Glendale, Arizona, United States
BioSante Site #171
🇺🇸Chandler, Arizona, United States
BioSante Site #014
🇺🇸Huntsville, Alabama, United States
BioSante Site #027
🇺🇸Glendale, Arizona, United States
BioSante Site #137
🇺🇸Tucson, Arizona, United States
BioSante Site #155
🇺🇸Little Rock, Arkansas, United States
BioSante Site #221
🇺🇸Berkeley, California, United States
BioSante Site #182
🇺🇸Buena Park, California, United States
BioSante Site #162
🇺🇸Sacramento, California, United States
BioSante Site #132
🇺🇸New Britain, Connecticut, United States
BioSante Site #159
🇺🇸Walnut Creek, California, United States
BioSante Site #026
🇺🇸Lakewood, Colorado, United States
BioSante Site #036
🇺🇸Ridgefield, Connecticut, United States
BioSante Site #151
🇺🇸New London, Connecticut, United States
BioSante Site #143
🇺🇸Jacksonville, Florida, United States
BioSante Site #111
🇺🇸Orlando, 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 #115
🇺🇸Atlanta, Georgia, United States
BioSante Site #202
🇺🇸Idaho Falls, Idaho, United States
BioSante Site #017
🇺🇸Meridian, Idaho, United States
BioSante Site #189
🇺🇸Addison, Illinois, United States
BioSante Site #133
🇺🇸Chicago, Illinois, United States
BioSante Site #167
🇺🇸Newburgh, Indiana, United States
BioSante Site #214
🇺🇸Lexington, Kentucky, United States
BioSante Site #110
🇺🇸Metarie, Louisiana, United States
BioSante Site #005
🇺🇸Shreveport, Louisiana, United States
BioSante Site #206
🇺🇸Fall River, Massachusetts, United States
BioSante Site #124
🇺🇸Bingham Farms, Michigan, United States
BioSante Site #047
🇺🇸Grand Rapids, Michigan, United States
BioSante Site #031
🇺🇸St. Clair Shores, Michigan, United States
BioSante Site #105
🇺🇸Kalamazoo, Michigan, United States
BioSante Site #033
🇺🇸Saginaw, Michigan, United States
BioSante Site #059
🇺🇸Cary, North Carolina, United States
BioSante Site #015
🇺🇸Poughkeepsie, New York, United States
BioSante Site #130
🇺🇸Beachwood, Ohio, United States
BioSante Site #104
🇺🇸St. Louis, Missouri, United States
BioSante Site #208
🇺🇸Edina, Minnesota, United States
BioSante Site #107
🇺🇸Raleigh, North Carolina, United States
BioSante Site #131
🇺🇸Winston-Salem, North Carolina, United States
BioSante Site #006
🇺🇸Lincoln, Nebraska, United States
BioSante Site #198
🇺🇸St. Paul, Minnesota, United States
BioSante Site #056
🇺🇸Fargo, North Dakota, United States
BioSante Site #210
🇺🇸Akron, Ohio, United States
BioSante Site #160
🇺🇸Englewood, Ohio, United States
BioSante Site #213
🇺🇸Columbus, Ohio, United States
BioSante Site #129
🇺🇸Tulsa, Oklahoma, United States
BioSante Site #138
🇺🇸West Chester, Ohio, United States
BioSante Site #153
🇺🇸Gallipolis, Ohio, United States
BioSante Site #106
🇺🇸Eugene, Oregon, United States
BioSante Site #099
🇺🇸Sellersville, Pennsylvania, United States
BioSante Site #165
🇺🇸Jenkintown, Pennsylvania, United States
BioSante Site #050
🇺🇸Eugene, Oregon, United States
BioSante Site #126
🇺🇸Medford, Oregon, United States
BioSante Site #117
🇺🇸Anderson, South Carolina, United States
BioSante Site #197
🇺🇸Wexford, Pennsylvania, United States
BioSante Site #089
🇺🇸Columbia, South Carolina, United States
BioSante Site #069
🇺🇸Chattanooga, Tennessee, United States
BioSante Site #078
🇺🇸Memphis, Tennessee, United States
BioSante Site #147
🇺🇸Dallas, Texas, United States
BioSante Site #181
🇺🇸Tacoma, Washington, United States
BioSante Site #188
🇨🇦Sarnia, Ontario, Canada
BioSante Site #035
🇺🇸Ann Arbor, Michigan, United States
BioSante Site #209
🇺🇸Greer, South Carolina, United States
BioSante Site #049
🇺🇸Watertown, South Dakota, United States
BioSante Site #141
🇺🇸Roswell, Georgia, United States
BioSante Site# 123
🇨🇦Ottawa, Ontario, Canada
BioSante Site #127
🇺🇸Billings, Montana, United States
BioSante Site #051
🇺🇸Missoula, Montana, United States