At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 945 enrolled
Drug / intervention
50 mg qhs +2 moredrug
Likely dose
50 mg qhsfrom 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 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder
In Brief
A Phase 3 clinical trial evaluating 50 mg qhs, 100 mg, and 1 other intervention for Sexual Dysfunctions, Psychological. Completed, enrolled 945 participants across 86 sites in 13 countries.
Detailed Summary
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women. To evaluate safety and tolerability of flibanserin in such patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSexual Dysfunctions, Psychological
CountriesAustria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionMar 2009
TodayJul 2026
First PostedJun 26, 2007
Enrollment StartJun 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.0 years ago
Interventions
50 mg qhsdrug
flibanserin 50 mg
100 mgdrug
flibanserin 100mg
placebodrug
placebo