NCT00491829

Flibanserin Versus Placebo in Premenopausal Women With HSDD

A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 945 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women. To evaluate safety and tolerability of flibanserin in such patients.

Conditions

• Sexual Dysfunctions, Psychological

Interventions

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

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-06-26
• Last updated: 2014-06-02
• Results posted: 2014-06-02

Locations

86 sites across 13 countries: Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom