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| |  Flibanserin Effectively Treats Women With Low Libido: Presented at ESSM By Jill Stein LYON, France -- November 17, 2009 -- The investigational agent flibanserin can be an effective treatment for women with hypoactive sexual desire disorder (HSDD), investigators stated at the 12th Congress of the European Society of Sexual Medicine (ESSM). While HSDD is the most common sexual problem in women, the only treatment currently available for the complaint is androgen replacement therapy, noted John Thorp, MD, University of North Carolina, Chapel Hill, North Carolina, speaking here at a presentation on November 17. Dr. Thorp and colleagues randomised 1,581 adult women after a 4-week baseline period to receive flibanserin 25 mg twice daily, flibanserin 50 mg twice daily, flibanserin 100 mg at bedtime, or placebo for 24 weeks. The study was conducted at 64 centres in the United States and 13 centres in Canada. All women in this study were premenopausal, with a primary diagnosis of generalised acquired HSDD, and were in a stable monogamous heterosexual relationship with a sexually functional partner. Coprimary endpoints were the change from baseline to study end in the number of satisfying sexual events (SSE) and sexual desire score measured using a daily electronic diary. Flibanserin 100 mg at bedtime improved the number of SSEs by 0.8 (P < .01) at study end compared with placebo. The other dosages of flibanserin improved the number of SSE at study end versus placebo; however, these differences were not statistically significant. There were also numerical but not statistically significant improvements in electronic diary desire scores in favour of flibanserin 100 mg at bedtime (1.7, P = .12), 50 mg twice daily (2.1, P = .06), and 25 mg twice daily (1.2, P = .28) at the end of the study. The study found that all flibanserin regimens significantly improved the Female Sexual Function Index (FSFI) domain, FSFI total, Female Sexual Distress Scale-Revised (FSDS-R) total and FSDS-R Item 13 scores versus placebo at study end (P < .05, for all comparisons). Funding for this study was provided by Boehringer Ingelheim. [Presentation title: Efficacy of Flibanserin as a Potential Treatment for Hypoactive Sexual Desire Disorder in North American Premenopausal Women: Results From the DAISY Trial. Abstract HP-03-002]
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