Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Phase 3
Completed
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Drug: placebo gel
- Registration Number
- NCT00657501
- Lead Sponsor
- BioSante Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 575
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description testosterone gel testosterone gel 1% testosterone transdermal gel Placebo gel placebo gel placebo transdermal gel
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Change from baseline over time for multiple efficacy measurements change over timepoints from baseline period
Trial Locations
- Locations (69)
BioSante Site #146
🇺🇸Mobile, Alabama, United States
BioSante Site #171
🇺🇸Chandler, Arizona, United States
BioSante Site #145
🇺🇸Glendale, Arizona, United States
BioSante Site #121
🇺🇸Phoenix, Arizona, United States
BioSante Site #137
🇺🇸Tucson, Arizona, United States
BioSante Site #100
🇺🇸Jonesboro, Arkansas, United States
BioSante Site #155
🇺🇸Little Rock, Arkansas, United States
BioSante Site #221
🇺🇸Berkely, California, United States
BioSante Site #162
🇺🇸Sacramento, California, United States
BioSante Site #112
🇺🇸San Diego, California, United States
Scroll for more (59 remaining)BioSante Site #146🇺🇸Mobile, Alabama, United States