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

BioSante Pharmaceuticals63 sites in 1 country597 target enrollmentDecember 2006

ConditionsHypoactive Sexual Desire Disorder

Interventionstestosterone gel placebo gel

Drugstestosterone gel placebo gel

Overview

Phase: Phase 3
Intervention: testosterone gel
Conditions: Hypoactive Sexual Desire Disorder
Sponsor: BioSante Pharmaceuticals
Enrollment: 597
Locations: 63
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

September 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

BioSante Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

testosterone gel

1% testosterone transdermal gel

Intervention: testosterone gel

placebo gel

placebo transdermal gel

Intervention: placebo gel

Outcomes

Primary Outcomes

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.

Time Frame: Baseline and 21-24 weeks.