At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 570 enrolled
Drug / intervention
Brisdelle (paroxetine mesylate) +1 moredrug
Likely dose
Brisdelle (paroxetine mesylate) 7.5 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 Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause
In Brief
A Phase 3 clinical trial evaluating Brisdelle (paroxetine mesylate) and Placebo capsules for Hot Flashes. Completed, enrolled 570 participants across 32 sites.
Detailed Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedApr 2010
Primary CompletionSep 2011
Study CompletionNov 2011
TodayJul 2026
First PostedApr 12, 2010
Enrollment StartMar 1, 2010
Primary CompletionSep 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.2 years ago
Interventions
Brisdelle (paroxetine mesylate)drug
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Placebo capsulesdrug
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.