Overview

This trial is active, not recruiting.

Condition menopause
Treatments oral micronized progesterone (prometrium®), placebo
Phase phase 2
Sponsor University of British Columbia
Start date September 2005
End date October 2009
Trial size 125 participants
Trial identifier NCT00152438, C03-0088

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Oral micronized progesterone
oral micronized progesterone (prometrium®) Oral micronized progesterone: Prometrium®, Uteroestan®
300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
(Placebo Comparator)
Placebo
placebo
3 identical placebo pills daily, no active ingredient.

Primary Outcomes

Measure
Vasomotor symptoms prospectively recorded in the final month of therapy by therapy assignment, with pre-therapy baseline vasomotor symptoms as a covariate.
time frame: Four months
Forearm blood flow by plethysmography prospectively measured before and after three months of therapy
time frame: Four months

Secondary Outcomes

Measure
Other hormone-related quality of life measures on the Daily Menopause Diary®, especially self worth, sleep, and energy, recorded during the 4 months of the study.
time frame: Four months
Changes in two Quality of Life instruments - the Rand SF-36 and the Menopause-specific Quality of Life (MenQoL) questionnaires, measured at baseline and at the end of the study period
time frame: Four months
Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period
time frame: Four months

Eligibility Criteria

Female participants from 40 years up to 65 years old.

Inclusion Criteria: 1. Menopausal women (final menstrual period one or more but less than 10 years before) 2. No evidence of vascular disease (normal BP; without diabetes mellitus; normal cholesterol levels and non-smoker for at least a year; and normal ECG.) 3. Moderate to severe VMS during the day and night. Exclusion Criteria: 1. Any menstruation in the preceding year. 2. History of hysterectomy without ovariectomy unless 60 years of age. 3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) or selective estrogen receptor modulator (SERM) therapy (raloxifene or tamoxifen) in the preceding six months. 4. Body mass index (BMI) over 35 or less than 20. 5. Mean of several pre-treatment blood pressures over 145/95. 6. Documented abnormal cholesterol; abnormal fasting capillary glucose; abnormal angiogram; ECG or exercise stress tests or a diagnosis of diabetes mellitus; or any history suggestive of angina.

Additional Information

Official title Vasomotor Symptoms and Endothelial Function—A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)
Principal investigator Jerilynn Prior
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by University of British Columbia.