Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

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.

Conditions

• Postmenopausal Symptoms

Interventions

DRUG

Brisdelle (paroxetine mesylate)

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

DRUG

Placebo capsules

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

Sponsors & Collaborators

• Noven Therapeutics

  lead INDUSTRY

Principal Investigators

• Corey Jacobs, MD

• Donna DeSantis, MD

• Robert Phillips, MD

• Louise Taber, MD

• Paige C. Brainard, MD

• Mark Stripling, MD

• Gioi Smith-Nguyen, MD

• Anthony Dulgeroff, MD

• Elise Kwon, MD

• Douglas Young, MD

• William Koltun, MD

• Dana Shipp, MD

• Eric Ross, MD

• Arthur Waldbaum, MD

• Theodore Cooper, MD

• J B. Stern, MD

• Paul DiGrazia, MD

• Robert Spitz, MD

• James A Simon, MD

• Mildred Farmer, MD

• James Andersen, MD

• Steven Bowman, MD

• Rene Casanova, MD

• Mary Yankaskas, MD

• Andrew Kaunitz, MD

• Ronald Surowitz, MD

• Lisa Cohen, MD

• Lisa Vendeland, MD

• Tyrone Malloy, MD

• Stephen C. Blank, MD

• Mark Turner, MD

• Carl R Lang, MD

• Arthur Donovan, MD

• Armen Arslanian, MD

• Shiao-Yu Lee, MD

• Gayle Moyer, MD

• Geoffrey Turner, MD

• Susan L Hendrix, MD

• Mark Barber, MD

• Stephen Swanson, MD

• Timothy Sauter, MD

• Steven Sussman, MD

• Elizabeth Bretton, MD

• Lance A. Rudolph, MD

• Kenneth Levey, MD

• Pouru Bhiwandi, MD

• Richard E. Hedrick, MD

• Gregory P Tarleton, MD

• Mira Baron, MD

• David J Portman, MD

• Milroy Samuel, MD

• Stuart Weprin, MD

• James Liu, MD

• Angelique Barreto, MD

• Marvin Kalafer, MD

• Larry S. Seidman, MD

• Saul R. Berg, MD

• Susan Floyd, MD

• Scott Wilson, MD

• Cynthia Strout, MD

• D. S. Harnsberger, MD

• Janet Dittus, MD

• Gregg Lucksinger, MD

• Anna Damian, MD

• Sandra Hurtado, MD

• Alfred Poindexter, MD

• Nancy Campbell, MD

• William Jennings, MD

• Jose Ruiz, MD

• John A. Hoekstra, MD

• Peter A. Zedler, MD

• Franklin Morgan, MD

• Robin Kroll, MD

• Derrick R Havin, MD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2011-12-31

Completion

2012-02-29

Countries

• United States

Study Locations