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Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause

NCT00786188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-10-15

Study results available
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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

Conditions

Interventions

DRUG

Brisdelle (paroxetine mesylate)

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

DRUG

Sugar pill

Subjects will receive a sugar pill.

Sponsors & Collaborators

  • Noven Therapeutics

    lead INDUSTRY

Principal Investigators

  • Patrick F. Freuen, MD · North Spokane Women's Clinic, Spokane, WA 99207

  • Richard E. Hedrick, MD · Hawthorne Medical Research, Inc., Winston-Salem, NC 27103

  • Samuel N. Lederman, MD · Altus Research, Lake Worth, FL 33461

  • Larry S. Seidman, DO · Philadelphia Clinical Research, LLC, Philadelphia, PA 19114

  • James E. Tomblin, MD · Hawthorne Medical Research, Inc., Greensboro, NC 27408

  • Peter A. Zedler, MD · Virginia Women's Center, Richmond, VA 23233

  • D. S. Harnsberger, MD · Chattanooga Medical Research, LLC, Chattanooga, TN 37404

  • John A. Hoekstra, MD · National Clinical Research, Inc., Richmond, VA 23294

  • Robin Kroll, MD · Women's Clinical Research Center, Seattle, WA 98105

  • Ashley Tunkle, MD · Anchor Research Center, Naples, FL 34102

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786188 on ClinicalTrials.gov