NCT00601367

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Conditions

• Sexual Dysfunctions, Psychological

Interventions

Type	Name	Description
DRUG	flibanserin flexible dose	Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening. Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-01-28
• Last updated: 2014-06-20
• Results posted: 2014-06-20

Locations

68 sites across 12 countries: Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom