At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,090 enrolled
Drug / intervention
Flibanserin +1 moredrug
Likely dose
Not stated in 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 (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
In Brief
A Phase 3 clinical trial evaluating Flibanserin and Placebo for Sexual Dysfunctions, Psychological. Completed, enrolled 1,090 participants across 75 sites.
Detailed Summary
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSexual Dysfunctions, Psychological
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionDec 2010
Study CompletionFeb 2011
TodayJul 2026
First PostedOct 16, 2009
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.7 years ago
Interventions
Flibanserindrug
patients will be randomized to flibanserin or placebo in a double-blind manner
Placebodrug
patients will be randomized to flibanserin or placebo in a double-blind manner