PI: Thorp, John MD

Anxiety disorders are among the most common psychiatric illnesses. Serotonin (5-hydroxytryptamine, 5-HT) is known to play an important role in anxiety through actions mediated by a wide family of receptors, including the 5-HT2 receptors. Flibanserin is a post-synaptic full serotonin (5-HT1A) agonist and a 5-HT2A antagonist. It was originally developed to treat depression. In Phase II depression trials, flibanserin was not associated with sexual dysfunction, which is commonly the case in some antidepressants. This was the basis for continuing the indication of Hypoactive Sexual Desire Disorder (HSDD)in premenopausal women. Female sexual dysfunction affects 20%-50% of women. A significant percentage of these women suffer from HSDD, which is characterized by a loss of sexual desire leading to distress. There is an absence of significant research on HSDD and the physiological support of this disorder is currently not known. Further research is necessary to assess presumed prosexual effects, establish dosing regimen and compare safety and efficacy of different doses and dose regimens of flibanserin in premenopausal women with HSDD for 24 weeks.

The definition and criteria for HSDD diagnosis are described in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision (DSM-IV-TR®),a review of all current criteria defining female sexual dysfunction.

The primary objective is to establish the efficacy of flibanserin over 24 weeks of treatment to produce a clinically meaningful therapeutic response in premenopausal women with HSDD and to document the safety profile of the administered flibanserin. The first co- primary endpoint is the change from baseline in the frequency of satisfying sexual events as measured by the electronic diary (eDiary). The second co-primary endpoint is the change from baseline in the monthly sum of responses to the eDiary daily desire questions. The comparisons for both will be made between the 4-week baseline period and Week 21 to 24.

The lead secondary endpoint will be to quantify the change in personal distress due to sexual dysfunction.

Participants:

Women over the age of 18 with a diagnosis of HSDD will be asked to participate in the 32- week trial.

Procedures (methods):

The participants will be randomly assigned to either study drug or placebo for 24 weeks. The study will involve questionnaires about depression, suicide and sexual health. Some of the procedures required are physical examinations, blood and urine tests, electrocardiogram and utilization of an electronic diary.