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24-Week Efficacy & Safety Study of Mesafem Capsules in the Treatment of VMS - NCT01101841-98105(Clinical Trial 597175)



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City:  Seattle
State:  
WA
Zip Code: 98105
Conditions: Vasomotor Symptoms - Menopause
Purpose: To assess the safety and efficacy of Mesafem for treatment of vasomotor symptoms (VMS) associated with menopause
Study summary: The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Mesafem capsules in subjects with moderate to severe postmenopausal VMS, defined as follows: 1. Moderate VMS: Sensation of heat with sweating, able to continue activity 2. Severe VMS: Sensation of heat with sweating, causing cessation of activity The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.
Criteria: Inclusion Criteria: 1. Female, >40 years of age 2. 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 3. Spontaneous amenorrhea for at least 12 consecutive months 4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause 5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy Exclusion Criteria: 1. BMI ≥ 40 kg/m² 2. Known non-responder to previous SSRI or SNRI treatment for VMS 3. Positive urine pregnancy test result at screening or at any time during study participation 4. History of hypersensitivity or adverse reaction to Mesafem 5. Use of an investigational study medication within 30 days prior to screening or during the study 6. Concurrent participation in another clinical trial or previous participation in this trial 7. Family of investigational-site staff
Study is available at: Women's Clinical Research Center
Seattle, WA 98105
United States

Primary Contact:
Hannah Kirshenbaum
Phone: 206-522-3330
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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