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

NCT00152438 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2011-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oral Micronized Progesterone (Prometrium®)

300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.

OTHER

Placebo

3 identical placebo pills daily, no active ingredient.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jerilynn Prior · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-10-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152438 on ClinicalTrials.gov