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About
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.
The main trial duration: December 1999 - May 2003.
The ancillary data analysis project duration: April 2006 - March 2010.
Full description
See Brief Summary above.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Postmenopausal WISE and nonWISE study participants
Normal/minimally diseased coronary arteries (<50% luminal diameter stenosis in all epicardial coronary arteries) within 36 months of ancillary study entry and no intercurrent MI, PTCA, CABG
Any one (or multiple) of the following criteria suggestive of myocardial ischemia within 36 months of ancillary study entry:
No contraindications to 12 weeks of FemHRT or hormone replacement therapy
Normal mammogram and pelvic exam (including PAP smear for those with an intact uterus) within 12 months of study entry
Documented normal liver function testing (SGOT) within 3 months of study entry.
Exclusion Criteria
Women with elevated diastolic (> or = 90 mm Hg) or systolic (> or = 140 mm Hg) blood pressure, LDL-cholesterol (> or = 160 mg/dl), fasting blood sugar (> or = 130 mg/dl) and women who smoke cigarettes will be told their risk factor levels and referred for evaluation and treatment by their private physician.
Primary purpose
Allocation
Interventional model
Masking
37 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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