24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3 Completed 880 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: 2008-04
Completion: 2008-04

Outcome

Mixed primary results

paper Flibanserin 50 mg and 100 mg led to increases in SSE (P < 0.05 and P < 0.01 vs. placebo, respectively). PMID 22248038 ↗

paper There was a numerical trend toward improvement in eDiary desire score on flibanserin 100 mg, but statistical significance was not reached (P = 0.07 vs. placebo). PMID 22248038 ↗

Publications

Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.

Drugs

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