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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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

Key facts

Study ID

NCT00786188

Run by

Noven Therapeutics

People needed

102

Starts

2008-11-01

Expected to finish

2009-06-01

Last updated by the study team

2015-10-15

Who can join

Age: 41 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, >40 years of age
• Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
• Spontaneous amenorrhea for at least 12 consecutive months
• Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
• Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

You may not qualify if…

• History of hypersensitivity or adverse reaction to paroxetine mesylate
• Use of an investigational study medication within 30 days prior to screening or during the study
• Concurrent participation in another clinical trial or previous participation in this trial
• Family of investigational-site staff

Where it is running

• Altus Research — Lake Worth, Florida, United States
• Anchor Research Center — Naples, Florida, United States
• Hawthorne Research — Greensboro, North Carolina, United States
• Hawthorne Medical Research, Inc. — Winston-Salem, North Carolina, United States
• Philadelphia Clinical Research — Philadelphia, Pennsylvania, United States
• Chattanooga Medical Research, LLC — Chattanooga, Tennessee, United States
• Virginia Women's Center — Richmond, Virginia, United States
• National Clinical Research, Inc. — Richmond, Virginia, United States
• Women's Clinical Research Center — Seattle, Washington, United States
• North Spokane Women's Clinic Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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