NCT00360555

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

Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,584 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sexual Dysfunctions, Psychological

Interventions

Type	Name	Description
DRUG	flibanserin	flibanserin 25 mg b.i.d
DRUG	flibanserin 50mg	flibanserin 50mg qhs/b.i.d.
DRUG	flibanserin 100mg	flibanserin 50 mg b.i.d/100mg qhs
DRUG	placebo	placebo comparator

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-08-04
• Last updated: 2016-06-27
• Results posted: 2016-06-27

Locations

77 sites across 2 countries: United States, Canada