Status:
UNKNOWN
Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone
Lead Sponsor:
University of British Columbia
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
Brief 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 b...
Detailed 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 an...
Eligibility Criteria
Inclusion
- Menopausal women (final menstrual period one or more but less than 10 years before)
- No evidence of vascular disease (normal BP; without diabetes mellitus; normal cholesterol levels and non-smoker for at least a year; and normal ECG.)
- Moderate to severe VMS during the day and night.
Exclusion
- Any menstruation in the preceding year.
- History of hysterectomy without ovariectomy unless 60 years of age.
- 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.
- Body mass index (BMI) over 35 or less than 20.
- Mean of several pre-treatment blood pressures over 145/95.
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00152438
Start Date
September 1 2005
End Date
December 1 2012
Last Update
September 22 2011
Active Locations (1)
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1
Centre for Menstrual Cycle and Ovulation Research
Vancouver, British Columbia, Canada