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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioSante Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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 transdermal gel or cream estrogen therapy.