To present the design of three Phase III North American trials, which will assess the efficacy and safety profile of flibanserin, a novel centrally acting agent, in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD).

The Dahlia (511.70), Violet (511.71), and Daisy (511.75) studies are prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials, designed to assess the effects of flibanserin in premenopausal women with a primary diagnosis of generalized, acquired HSDD. Every study consists of a 4-week baseline period (no medication), 24-week double-blind treatment period, and 4-week follow-up period after discontinuation of study medication. Designs are identical except for the flibanserin doses tested: 25 mg bid/50 mg bid/50 mg qhs/placebo in Dahlia; 50 mg qhs/100 mg qhs/placebo in Violet; 25 mg bid/50 mg qhs uptitrated to 50 mg bid/50 mg qhs uptitrated to 100 mg qhs/placebo in Daisy. Co-primary endpoints are monthly sum of responses to a daily question on sexual desire measured by an electronic diary (e-Diary For HSDD Trials©; e-Diary), comparing 4-week baseline with weeks 21-24, and change in frequency of satisfying sexual events, measured by the e-Diary. Secondary endpoints include change in distress related to sexual desire. Prospective safety assessments include evaluation of menses and sex hormones adverse events.

These trials are ongoing. Results will be presented in 2009.

These North American Phase III trials will determine the efficacy and safety of 24 weeks’flibanserin treatment in premenopausal women with HSDD, and determine minimal effective and most tolerable dosages for this indication.

Funding was provided by Boehringer Ingelheim.