Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (W007)

Trial name: TestW007: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Trial sponsors: BioSante Pharmaceuticals, Inc.

Study start date: January 2008

Estimated study completion date: January 1014

Trial purpose and overview: This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least one risk factor risk for cardiovascular disease and have a clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Study location(s) and contact:

Contact
Name: Joanne Zborowski
Email: jzborowski@biosantepharma.com
Phone number: 847-478-0500 Ext. 104

Locations

United States, Alabama
Recruiting
Huntsville, Alabama, United States

Recruiting
Mobile, Alabama, United States

United States, Arizona
Recruiting
Phoenix, Arizona, United States
Recruiting
Glendale, Arizona, United States

Recruiting
Tucson, Arizona, United States

United States, Arkansas
Recruiting
Jonesboro, Arkansas, United States
Recruiting
Little Rock, Arkansas, United States

United States, California
Recruiting
San Diego, California, United States

Recruiting
Walnut Creek, California, United States

Recruiting
Los Angeles, California, United States
Recruiting
Carmichael, California, United States

United States, Colorado
Recruiting
Denver, Colorado, United States

United States, Connecticut
Recruiting
Hartford, Connecticut, United States
Recruiting
Farmington, Connecticut, United States
Recruiting
New London, Connecticut, United States
Recruiting
New Britain, Connecticut, United States

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

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

Recruiting
Crystal River, Florida, United States
Recruiting
Tampa, Florida, United States

United States, Illinois
Recruiting
Chicago, Illinois, United States
Recruiting
Champaign, Illinois, United States

United States, Indiana
Recruiting
Newburgh, Indiana, United States

United States, Kansas
Recruiting
Overland Park, Kansas, United States

United States, Maryland
Recruiting
Baltimore, Maryland, United States

United States, Michigan
Recruiting
Paw Paw, Michigan, United States
Recruiting
Bingham Farms, Michigan, United States

United States, Missouri
Recruiting
St. Louis, Missouri, United States

United States, Montana
Recruiting
Billings, Montana, United States

United States, Nebraska
Recruiting
Lincoln, Nebraska, United States

United States, New Jersey
Recruiting
Lawrenceville, New Jersey, United States

United States, New York
Recruiting
Purchase, New York, United States
Recruiting
Brooklyn, New York, United States

United States, North Carolina
Recruiting
Raleigh, North Carolina, United States
Recruiting
Winston Salem, North Carolina, United States

United States, Ohio
Recruiting
Beechwood, Ohio, United States
Recruiting
Englewood, Ohio, United States
Recruiting
Cleveland, Ohio, United States
Recruiting
Gallipolis, Ohio, United States
Recruiting
Mayfield Heights, Ohio, United States
Recruiting
Westchester, Ohio, United States

United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States

United States, Oregon
Recruiting
Eugene, Oregon, United States
Recruiting
Medford, Oregon, United States

United States, Pennsylvania
Recruiting
Jenkintown, Pennsylvania, United States
Recruiting
Pittsburgh, Pennsylvania, United States

United States, South Carolina
Recruiting
Anderson, South Carolina, United States

United States, Tennessee
Recruiting
Germantown, Tennessee, United States

United States, Texas
Recruiting
Houston, Texas, United States
Recruiting
Dallas, Texas, United States
Recruiting
Hurst, Texas, United States

United States, Utah
Recruiting
Salt Lake City, Utah, United States
Recruiting
Sandy, Utah, United States

United States, Virginia
Recruiting
Charlottesville, Virginia, United States

United States, Washington
Recruiting
Seattle, Washington, United States

United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States

Actively recruiting volunteers; Does not enroll healthy volunteers.

Ages eligible for study: 50+

Inclusion criteria:
Postmenopausal female subjects will be

at least 50 years of age
have at least one risk factor for cardiovascular disease
have a clinical diagnosis of HSDD.

Exclusion criteria:
Subject must not

require treatment with anti-androgens, tamoxifen or other selective estrogen receptor modulators (treatment and prevention of osteoporosis is acceptable),

have a history of estrogen-dependent neoplasia or any gynecologic cancer within 10 years,

have a history of malignant melanoma or a history of invasive cancer at any time, have a screening mammogram with pre-cancerous or cancerous findings or any finding that requires follow up within 6 months of randomization,

have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Other Information Relevant to this Posting

www.bloomstudy.com

posted August 20, 2008