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.
Primary Outcome Measures:
- Vasomotor symptoms prospectively recorded during the first month compared with changes in months one, two and three of the study [ Time Frame: Four months ] [ Designated as safety issue: No ]
- Forearm blood flow by plethysmography prospectively measured before and after three months of therapy [ Time Frame: Four months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Lipid, blood pressure (BP), waist circumference and weight changes, measured at baseline and at the end of the study period [ Time Frame: Four months ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
125 |
| Study Start Date: |
September 2005 |
| Estimated Study Completion Date: |
December 2010 |
| Estimated Primary Completion Date: |
December 2010 (Final data collection date for primary outcome measure) |
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1: Experimental
Oral micronized progesterone
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Drug: Oral Micronized Progesterone (Prometrium®)
300 mg per day in 3 - 100 mg pills, to be taken in the evening immediately before sleep.
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2: Placebo Comparator
Placebo
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Other: Placebo
3 identical placebo pills daily, no active ingredient.
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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.
Purpose
