Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3 Completed 1584 enrolled Sprout Pharmaceuticals, Inc

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Timeline

Start: 2006-07
Primary completion: 2008-03
Completion: 2008-03

Outcome

Mixed primary results

paper 100 mg once daily was associated with an increase in SSE (P<0.01 vs. placebo) PMID 22239862 ↗

paper No group showed a significant increase in eDiary desire score vs. placebo. PMID 22239862 ↗

Publications

Thorp J, Simon J, Dattani D, Taylor L, Kimura T, Garcia M Jr, Lesko L, Pyke R; DAISY trial investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012 Mar;9(3):793-804. doi: 10.1111/j.1743-6109.2011.02595.x. Epub 2012 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	flibanserin	Small molecule	25 mg	—
Subject	flibanserin	Small molecule	50 mg	—
Subject	flibanserin	Small molecule	100 mg	—