24-Week Efficacy & Safety Study of Mesafem Capsules in the Treatment of VMS

2014-08-27 03:14:39 | BioPortfolio


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.

Study Design

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


Vasomotor Symptoms


Mesafem Capsules


East Valley Family Physicians PLC
United States




Noven Pharmaceuticals

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:39-0400

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