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

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

Summary

To assess the safety and efficacy of Mesafem for treatment of vasomotor symptoms (VMS) associated with menopause

Description

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

Conditions

Vasomotor Symptoms

Intervention

Mesafem Capsules

Location

East Valley Family Physicians PLC
Chandler
Arizona
United States
85224

Status

Recruiting

Source

Noven Pharmaceuticals

Results (where available)

View Results

Links

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

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