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

Summary

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

Conditions

• Hot Flashes

Interventions

DRUG

Brisdelle (paroxetine mesylate)

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

DRUG

Placebo capsules

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

Sponsors & Collaborators

• Noven Therapeutics

  lead INDUSTRY

Principal Investigators

• Derrick R Havin, MD · North Spokane Women's Clinic Research, 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

• Matthew Davis, MD · Rochester Clinical Research, Rochester, NY 14609

• Donna DeSantis, MD · East Valley Family Physicians PLC, Chandler, AZ 85224

• Steven Drosman · Genesis Center For Clinical Research, San Diego, CA 92103

• Mildred Farmer, MD · Meridien Research, Brooksville, FL 34601

• Sandra Hurtado, MD · The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054

• Bruce Levine, MD · Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057

• Tyrone Malloy, MD · Soapstone Center for Clinical Research, Decatur, GA 30034

• Eric Ross, MD · Apex Research Institute, Santa Ana, CA 92705

• Cynthia Strout, MD · Coastal Carolina Research Center, Mt. Pleasant, SC 29464

• Arthur Waldbaum, MD · Downtown Women's Health Care, Denver, CO, 80218

• Edward Zbella, MD · Women's Medical Research Group, LLC, Clearwater, FL 33759

• James R Dockery, MD · Montgomery Women's Health Associates, PC, Montgomery, AL 36116

• Stephen C Blank, MD · Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328

• Keith Aqua, MD · Visions Clinical Research, Boynton Beach, FL 33472

• Saul R Berg, MD · Clinical Trials Research Services, LLC, Pittsburgh, PA 15206

• Marvin Kalafer, MD · The Clinical Trial Center, LLC, Jenkintown, PA 19046

• David J Portman, MD · Columbus Center for Women's Health Research, Columbus, Ohio 43213

• Stephen Swanson, MD · Women's Clinic of Lincoln, PC, Lincoln, NE 68510

• Joseph Soufer, MD · Chase Medical Research, LLC, Waterbury, CT 06708

• ShaH R Scott, MD · Clinical Research Associates, Inc., Nashville, TN 37203

• Mary K Neuffer, MD · SC Clinical Research Center, LLC, Columbia, SC 29201

• Ronald Ackerman, MD · Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2011-09-30

Completion

2011-11-30

Countries

• United States

Study Locations