Status:
COMPLETED
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Lead Sponsor:
BioSante Pharmaceuticals
Conditions:
Hypoactive Sexual Desire Disorder
Eligibility:
FEMALE
30-65 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Must be between the ages of 30 to 65 years
- Must have undergone hysterectomy and bilateral salpingo-oophorectomy
Exclusion
- 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 topical gel or cream estrogen therapy.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
597 Patients enrolled
Trial Details
Trial ID
NCT00613002
Start Date
December 1 2006
End Date
September 1 2011
Last Update
January 10 2013
Active Locations (63)
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1
BioSante Site #215
Birmingham, Alabama, United States, 35209
2
BioSante Site #095
Hoover, Alabama, United States, 35216
3
BioSante Site #014
Huntsville, Alabama, United States, 35801
4
BioSante Site #027
Glendale, Arizona, United States, 85308