At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,385 enrolled
Drug / intervention
flibanserin +3 moredrug
Likely dose
flibanserin 25 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.
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
In Brief
A Phase 3 clinical trial evaluating flibanserin and placebo for Sexual Dysfunctions, Psychological. Completed, enrolled 1,385 participants across 81 sites.
Detailed 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 meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSexual Dysfunctions, Psychological
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionApr 2008
TodayJul 2026
First PostedAug 4, 2006
Enrollment StartJul 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago
Interventions
flibanserindrug
Experimental: flibanserin 25 mg b.i.d
flibanserindrug
Experimental: flibanserin 50mg qhs
flibanserindrug
Experimental: flibanserin 50mg b.i.d.
placebodrug
placebo