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

Completed · Phase 3 · Has a placebo group

Conditions studied: Postmenopausal Symptoms

In brief

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.

Key facts

Study ID

NCT01361308

Run by

Noven Therapeutics

People needed

614

Starts

2011-05-01

Expected to finish

2012-02-01

Last updated by the study team

2015-10-15

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, ≥ 40 years of age at screening (inclusive)
• 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 to the screening visit
• Spontaneous amenorrhea for at least 12 consecutive months or
• Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
• Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

You may not qualify if…

• Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
• History of self injurious behavior
• History of clinical diagnosis of depression or treatment for depression
• History of clinical diagnosis of borderline personality disorder
• 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

• East Valley Family Physicians PLC — Chandler, Arizona, United States
• Advanced Research Associates — Glendale, Arizona, United States
• Premier Research Group Limited — Peoria, Arizona, United States
• Verona Clinical Research, Inc — Tucson, Arizona, United States
• NEA Baptist Women's Clinic — Jonesboro, Arkansas, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• High Desert Medical Group — Lancaster, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Northern California Research — Sacramento, California, United States
• University Clinical Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• The Women's Clinic of Northern Colorado — Fort Collins, Colorado, United States
• Danbury Clinical Research, LLC — Danbury, Connecticut, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• James A. Simon, MD, PC — Washington D.C., District of Columbia, United States
• Meridien Research — Bradenton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
• DBC Research — Deerfield Beach, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• University of Florida College of Medicine - Jacksonville Southside Women's Health — Jacksonville, Florida, United States
• Wilmax Clinical Research — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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