At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,584 enrolled
Drug / intervention
flibanserin +3 moredrug
Likely dose
flibanserin 50mgfrom 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.
Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America
In Brief
A Phase 3 clinical trial evaluating flibanserin, flibanserin 50mg, and 2 other interventions for Sexual Dysfunctions, Psychological. Completed, enrolled 1,584 participants across 77 sites in 2 countries.
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 meets 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
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedAug 4, 2006
Enrollment StartJul 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.9 years ago
Interventions
flibanserindrug
flibanserin 25 mg b.i.d
flibanserin 50mgdrug
flibanserin 50mg qhs/b.i.d.
flibanserin 100mgdrug
flibanserin 50 mg b.i.d/100mg qhs
placebodrug
placebo comparator