At a glance
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Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study
In Brief
A clinical study evaluating 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate, and 2 other interventions for Postmenopausal Vasomotor Symptoms and Cardiovascular Disease. Completed, enrolled 160 participants across 1 site.
Detailed Summary
Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ. Aims of the present project are 1. to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms 2. in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.
Study Details
Timeline
Interventions
2mg oral daily for 6 months
2mg E2 + 5mg MPA daily for 6 months
1 mg skin gel daily for 6 months
placebo daily for 6 months