Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone

Menopause Clinical Trial

Official title: Vasomotor Symptoms and Endothelial Function—A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)

Status Active, not recruiting

Clinical Trial Summary

The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe VMS.

The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.

Clinical Trial Description

In this 4-month study, menopausal women are randomized to either placebo or oral micronized progesterone (Prometrium®). Participants maintain a daily diary to keep track of their vasomotor symptoms and other factors. Forearm blood flow will be assessed by venous occlusion plethysmography at baseline and after three months of therapy. Screening tests at baseline to rule out heart disease include measurement of blood pressure and heart rate, electrocardiogram (ECG) and blood tests - fasting blood glucose and lipid profile.

Collection of serum and plasma samples at baseline and end of therapy for analysis of cardiovascular markers (e.g., c-reactive protein) and clotting and fibrinolytic markers. Continued daily diary collection for one month after therapy discontinuation to look for possible rebound effects. Analysis of outcomes will be by analysis of covariates, with final value as the outcome, therapy as factor and baseline values as covariate. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

• NCT number: NCT00152438
• Study type: Interventional
• Source: University of British Columbia
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2005
• Completion date: December 2012