Trial Information

Summary: Hypoactive Sexual Desire Disorder

The study will help evaluate the long-term safety and efficacy of daily topical applications of LibiGel, an investigational drug, compared to placebo gel (an inactive substance) in the treatment of Hypoactive Sexual Desire Disorder in postmenopausal women. The study consists of a screening period of up to 4 weeks and a 60-month treatment period. Subjects will complete 9 office visits and 5 telephone contacts during the course of the study. Also, the study will follow subjects for heart blood vessel disease events and breast cancers for up to 5 years.

Patient Inclusion Criteria:

• Natural menopausal women 50 years of age or older with a diagnosis of HSDD
• Subjects with hysterectomy only must meet following menopause criteria: 50 to 54 years must be experiencing hot flushes or receiving estrogen therapy for hot flushes
• At least one risk factor for heart blood vessel disease including: 70 years or greater, type 2 diabetes, high blood pressure, smoking, or taking medication to treat high blood pressure
• Agrees to provide research site with contact information throughout the study period, which will last up to 5 years

Additional inclusion and exclusion criteria apply and will be reviewed with you.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.