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To assess the safety and efficacy of Mesafem for treatment of vasomotor symptoms (VMS) associated with menopause
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
East Valley Family Physicians PLC
Published on BioPortfolio: 2014-08-27T03:14:39-0400
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