Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Phase 3 Completed 949 enrolled Sprout Pharmaceuticals, Inc

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Timeline

Start: 2009-10
Primary completion: 2011-03
Completion: 2011-03

Outcome

Met primary endpoint

paper There were significant improvements with flibanserin versus placebo in the mean (SE) changes in the number of SSEs (1.0 [0.1] vs 0.6 [0.1]) PMID 24281236 ↗

paper all P < 0.01 PMID 24281236 ↗

Publications

Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-40. doi: 10.1097/GME.0000000000000134.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	flibanserin	Small molecule	100 mg	Oral