Status:
COMPLETED
Safety and Efficacy of LibiGel® for 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 transdermal gel or cream estrogen therapy.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT00657501
Start Date
March 1 2008
End Date
September 1 2011
Last Update
January 10 2013
Active Locations (69)
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1
BioSante Site #146
Mobile, Alabama, United States, 36608
2
BioSante Site #171
Chandler, Arizona, United States, 85224
3
BioSante Site #145
Glendale, Arizona, United States, 85306
4
BioSante Site #121
Phoenix, Arizona, United States, 85015