PI: Thorp, John MD

The purpose of this study is to establish the long-term safety and tolerability of flibanserin in the treatment of Hypoactive Sexual Desire Disorder (HSDD). This classification of female sexual dysfunction is characterized by a loss of sexual desire leading to distress.

The primary endpoint is the frequency of adverse events.

Women with a primary diagnosis of HSDD who have completed a prior clinical trial of flibanserin will be asked to participate in the 52-week open-label treatment trial.

There are 4 parts to the study, screening, baseline, open-label and post-treatment periods. Study participation can last approximately 57 weeks. The participants will receive flibanserin and begin taking 50 mg tablets every evening at bedtime. The dosage may be increased or decreased during this time based on the effectiveness of the dose and side effects. There will be 9 study visits and 3 telephone interviews. The study will involve questionnaires about depression, suicide and sexual health. Some of the procedures required are physical examinations, blood and urine tests, and electrocardiogram.