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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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

Key facts

Study ID

NCT01101841

Run by

Noven Therapeutics

People needed

570

Starts

2010-03-01

Expected to finish

2011-11-01

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
• 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…

• BMI ≥ 40 kg/m²
• 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

• Montgomery Women's Health Associates, PC — Montgomery, Alabama, United States
• East Valley Family Physicians PLC — Chandler, Arizona, United States
• Genesis 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
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Anchor Research Center — Naples, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Phoenix Ob-Gyn Associates, LLC — Moorestown, New Jersey, United States
• Rochester Clinical Research — Rochester, New York, United States
• Hawthorne Research — Greensboro, North Carolina, United States
• Hawthorne Medical Research, Inc. — Winston-Salem, North Carolina, United States
• Columbus Center for Women's Health Research — Columbus, Ohio, United States
• The Clinical Trial Center, LLC — Jenkintown, Pennsylvania, United States
• Philadelphia Clinical Research — Philadelphia, Pennsylvania, United States
• Clinical Trials Research Services, LLC — Pittsburgh, Pennsylvania, United States
• SC Clinical Research Center, LLC — Columbia, South Carolina, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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