CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 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/NCT00786188
NCT00786188Phase 2Completed
CompareCT.gov

A Phase 2, Exploratory, Eight-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 Nov 6, 2008·Updated Oct 15, 2015

In Brief

A Phase 2 clinical trial evaluating Brisdelle (paroxetine mesylate) and Sugar pill for Hot Flashes. Completed, enrolled 102 participants across 10 sites.

Detailed Summary

This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows: * Moderate VMS: Sensation of heat with sweating, able to continue activity * Severe VMS: Sensation of heat with sweating, causing cessation of activity

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.7 years ago

Interventions

Brisdelle (paroxetine mesylate)drug

Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.

Sugar pilldrug

Subjects will receive a sugar pill.