At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 880 enrolled
Drug / intervention
flibanserindrug
Likely dose
flibanserin 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.
A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America
In Brief
A Phase 3 clinical trial evaluating flibanserin for Sexual Dysfunctions, Psychological. Completed, enrolled 880 participants across 54 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 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
flibanserin placebo versus 50 mg qhs versus 100 mg qhs