Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women (W006)

Trial name: TESTW006 – “A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women”

Trial sponsors: BioSante Pharmaceuticals, Inc.

Study start date: December 2006

Estimated study completion date: December 2009

Trial purpose and overview: This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® in the treatment of HSDD in surgically menopausal women taking a stable dose of estrogen therapy.

Study location(s) and contact:

Contact
Name: Michael Elisseou, Ph.D.
Email: melisseou@biosantepharma.com
Phone number: 847-478-0500 Ext. 102

Locations

United States, Alabama
Recruiting
Huntsville, Alabama, United States

United States, California
Recruiting
Los Angeles, California, United States
Recruiting
San Diego, California, United States

United States, Colorado
Recruiting
Denver, Colorado, United States

United States, District of Columbia
Recruiting
Washington, District of Columbia, United States

United States, Florida
Recruiting
West Palm Beach, Florida, United States

United States, Maryland
Recruiting
Baltimore, Maryland, United States

United States, Nebraska
Recruiting
Lincoln, Nebraska, United States

United States, Tennessee
Recruiting
Germantown, Tennessee, United States

United States, Virginia
Recruiting
Charlottesville, Virginia, United States

Actively recruiting volunteers; Does not enroll healthy volunteers.

Ages eligible for study: 30 to 65

Inclusion criteria:

must be between the ages of 30 to 65 years
must have undergone hysterectomy and bilateral salpingo-oophorectomy
must be taking a stable dose of estrogen therapy

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 topical gel or cream estrogen therapy.

Other Information Relevant to this Posting

www.bloomstudy.com

posted: August 20, 2008