Safety and Efficacy of LibiGel® for the 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

NCT00613002

Run by

BioSante Pharmaceuticals

People needed

597

Starts

2006-12-01

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 topical gel or cream estrogen therapy.

Where it is running

• BioSante Site #095 — Hoover, Alabama, United States
• BioSante Site #014 — Huntsville, Alabama, United States
• BioSante Site #027 — Glendale, Arizona, United States
• BioSante Site #040 — Tucson, Arizona, United States
• BioSante Site #052 — Hot Springs, Arkansas, United States
• BioSante Site #182 — Buena Park, California, United States
• BioSante Site #008 — San Diego, California, United States
• BioSante Site #007 — Denver, Colorado, United States
• BioSante Site #216 — Denver, Colorado, United States
• BioSante Site #036 — Ridgefield, Connecticut, United States
• BioSante Site #013 — Washington D.C., District of Columbia, United States
• BioSante Site #024 — Miami, Florida, United States
• BioSante Site #219 — Pinellas Park, Florida, United States
• BioSante Site #041 — St. Petersburg, Florida, United States
• BioSante Site #009 — West Palm Beach, Florida, United States
• BioSante Site #189 — Addison, Illinois, United States
• BioSante Site #005 — Shreveport, Louisiana, United States
• BioSante Site #004 — Baltimore, Maryland, United States
• BioSante Site #044 — Detroit, Michigan, United States
• BioSante Site #047 — Grand Rapids, Michigan, United States
• BioSante Site #033 — Saginaw, Michigan, United States
• BioSante Site #031 — Saint Clair Shores, Michigan, United States
• BioSante Site #208 — Edina, Minnesota, United States
• BioSante Site #198 — Saint Paul, Minnesota, United States
• BioSante Site #215 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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