NCT01103362

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Conditions

• Sexual Dysfunctions, Psychological

Interventions

Type	Name	Description
DRUG	flibanserin	all patients will receive open-label flibanserin 100mg

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-04-14
• Last updated: 2014-05-12
• Results posted: 2014-05-12

Locations

95 sites across 2 countries: United States, Canada