Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone
Recruitment status was: Active, not recruiting
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.
|Menopause||Drug: Oral Micronized Progesterone (Prometrium®) Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Vasomotor Symptoms and Endothelial Function—A Randomized Placebo-controlled Trial of Oral Micronized Progesterone (Prometrium®)|
- 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 ]
- 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 ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Oral micronized progesterone
Drug: Oral Micronized Progesterone (Prometrium®)
300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
Other Name: Oral micronized progesterone: Prometrium®, Uteroestan®
Placebo Comparator: 2
3 identical placebo pills daily, no active ingredient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152438
|Canada, British Columbia|
|Centre for Menstrual Cycle and Ovulation Research|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Jerilynn Prior||University of British Columbia|