A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Phase 3 Terminated 1723 enrolled Sprout Pharmaceuticals, Inc

NaSingle-groupOpen-labelTreatment

Summary

To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

Timeline

Start: 2007-02
Primary completion: 2009-08
Completion: 2009-08

Outcome

Outcome not reported

Stopped: “terminated for administrative reasons”

Publications

Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012 Dec;9(12):3180-8. doi: 10.1111/j.1743-6109.2012.02942.x. Epub 2012 Oct 11.

Drugs

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