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

Phase 3

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Drug: testosterone gel; Drug: placebo gel

• Registration Number: NCT00613002
• Lead Sponsor: BioSante Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-02-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-04
• Disposition First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Disposition First Posted: 2013-01-10
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 597

Inclusion Criteria

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone gel	testosterone gel	1% testosterone transdermal gel
placebo gel	placebo gel	placebo transdermal gel

Primary Outcome Measures

Name	Time	Method
Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.	Baseline and 21-24 weeks.

Secondary Outcome Measures

Name	Time	Method
Change from baseline over time for multiple efficacy measurements	change over timepoints from baseline

Trial Locations

Locations (63)

BioSante Site #215; 🇺🇸 Birmingham, Alabama, United States

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

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