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| |  Flibanserin Provides Multiple Benefits in Women With Low Sexual Desire: Presented at ESSM By Jill Stein LYON, France -- November 20, 2009 -- The investigational agent flibanserin significantly increases the number of sexually satisfying events (SSE), sexual desire, and several other measures in premenopausal women with generalised acquired hypoactive sexual desire disorder (HSDD), according to data reported here on November 18 at the 12th Congress of the European Society of Sexual Medicine (ESSM). Elaine Jolly, MD, Obstetrics and Gynaecology, University of Ottawa, Ottawa, Ontario, and colleagues presented pooled data from two 24-week, randomised, placebo-controlled North American trials (VIOLET, 511.71 and DAISY, 511.75) that examined the efficacy of flibanserin 100 mg qhs in women with generalised acquired HSDD. The analysis included 1,378 premenopausal women aged 18 years or older with a primary diagnosis of generalised acquired HSDD who were in a stable monogamous heterosexual relationship with a sexually functional partner. The diagnosis of generalised acquired HSDD relied on an extensive interview with a clinician with expertise in the diagnosis of female sexual dysfunction. Coprimary endpoints included the change from baseline to study end in the number of satisfying sexual events (SSE) and electronic diary (eDiary) desire score. Secondary measures included Female Sexual Function Index (FSFI) desire domain, FSFI total, Female Sexual Distress Scale-Revised (FSDS-R) total, and FSDS-R Item 13 scores. Compared with baseline, flibanserin 10 mg qhs improved the number of SSE by 0.8 (P < .001) and eDiary score by 1.9 (P < .05) at the end of the study. Compared with placebo, flibanserin 100 mg qhs also improved FSFI desire domain score by 0.3 (P < .0001) and FSFI total score by 1.9 (P < .0001) at the end of the trial. Secondary measures also improved with flibanserin treatment. Specifically, flibanserin improved FSDS-R item 13 score by -0.3 (P < .001) and FSDS-R total score by -3.2 (P < .0001) compared with placebo at the end of the study. Funding for this study was provided by Boehringer Ingelheim. [Presentation Title: Efficacy of Flibanserin 100 mg QHS as a Potential Treatment for Hypoactive Sexual Desire Disorder in North American Premenopausal Women: Abstract PO-11-03]
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