ISRCTN16052610CompletedNot Applicable
Vasomotor symptoms (VMS) and endothelial function: A randomised placebo-controlled trial of oral micronised Progesterone (Prometrium ®)
Centre for Menstrual Cycle and Ovulation Research (CeMCOR) (Canada)0 sites165 target enrollmentStarted: May 10, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Women past menopause who are between one and ten years of their last menstrual period, not on any hormones for at least the past 6 months, experiencing hot flushes or night sweats and without any history or risk factors of heart disease (smoking, overweight, high lipid levels).
Exclusion Criteria
- •Amendment to protocol as of 17/05/2006:
- •1. Any menstruation in the preceding year
- •2. History of hysterectomy without ovariectomy unless she is 60 years of age
- •3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) in the preceding six months
- •4. Any risk factors for heart disease like smoker, high blood pressure, high cholesterol, diabetes, overweight, and history of angina or abnormal electrocardiogram (ECG)
Investigators
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