At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 614 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.

Search/NCT01361308

NCT01361308Phase 3Completed

Compare CT.gov

A Phase 3, Twelve-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

Noven Therapeutics·interventional·Posted May 26, 2011·Updated Oct 15, 2015

In Brief

A Phase 3 clinical trial evaluating Brisdelle (paroxetine mesylate) and Placebo capsules for Postmenopausal Symptoms. Completed, enrolled 614 participants across 74 sites.

Detailed Summary

The purpose of this study is to assess the safety \& 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--

ConditionsPostmenopausal Symptoms

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartMay 2011

First PostedMay 2011

Primary CompletionDec 2011

Study CompletionFeb 2012

TodayJul 2026

First PostedMay 26, 2011

Enrollment StartMay 1, 2011

Primary CompletionDec 1, 2011

Study CompletionFeb 1, 2012

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 15.1 years ago

Interventions

Brisdelle (paroxetine mesylate)drug

Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Placebo capsulesdrug