CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 480 enrolled
Drug / intervention
flibanserin flexible dosedrug
Likely dose
flibanserin flexible dose 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00601367
NCT00601367Phase 3Completed
CompareCT.gov

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

Sprout Pharmaceuticals, Inc·interventional·Posted Jan 28, 2008·Updated Jun 20, 2014

In Brief

A Phase 3 clinical trial evaluating flibanserin flexible dose for Sexual Dysfunctions, Psychological. Completed, enrolled 480 participants across 68 sites in 12 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSexual Dysfunctions, Psychological
CountriesAustria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartJan 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

flibanserin flexible dosedrug

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.