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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoactive Sexual Desire Disorder

In brief

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.

Key facts

Study ID

NCT00657501

Run by

BioSante Pharmaceuticals

People needed

575

Starts

2008-03-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-10

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Must be between the ages of 30 to 65 years
• Must have undergone hysterectomy and bilateral salpingo-oophorectomy

You may not qualify if…

• 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.

Where it is running

• 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
• BioSante Site #159 — Walnut Creek, California, United States
• BioSante Site #026 — Lakewood, Colorado, United States
• BioSante Site #166 — Farmington, Connecticut, United States
• BioSante Site #132 — New Britain, Connecticut, United States
• BioSante Site #151 — New London, Connecticut, United States
• BioSante Site #143 — Jacksonville, Florida, United States
• BioSante Site #111 — Orlando, Florida, United States
• BioSante Site #152 — Tampa, Florida, United States
• BioSante Site #115 — Atlanta, Georgia, United States
• BioSante Site #141 — Roswell, Georgia, United States
• BioSante Site #202 — Idaho Falls, Idaho, United States
• BioSante Site #017 — Meridian, Idaho, United States
• BioSante Site #156 — Champaign, Illinois, United States
• BioSante Site #045 — Chicago, Illinois, United States
• BioSante Site #149 — Chicago, Illinois, United States
• BioSante Site #146 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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