NCT00360529

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

A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 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.

Detailed description

This trial was designed as a prospective, multicenter trial containing a 24-week, randomized, double blind, placebo controlled, parallel-group period that assessed the effects of flibanserin (maximum total daily dose: 100 mg q.d.) compared with placebo in premenopausal women with HSDD, determined by Diagnostic and Statistical Manual IV- Text Revision (DSM IV-TR®) criteria. Three hundred patients were to be randomized to each treatment group. This trial examined the safety and efficacy of flibanserin compared to placebo for 24 weeks.

Conditions

• Sexual Dysfunctions, Psychological

Interventions

Type	Name	Description
DRUG	flibanserin	flibanserin placebo versus 50 mg qhs versus 100 mg qhs

Timeline

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

Locations

54 sites across 2 countries: United States, Canada