An interventional study of 17-b-estradiol and 17-b-estradiol + medroxyprogeterone acetate in Postmenopausal Vasomotor Symptoms and Cardiovascular Disease, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to female participants aged 48 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment
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
We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 160 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Postmenopausal women with severe vasomotor symptoms
Drug: 17-b-estradiol · Drug: 17-b-estradiol + medroxyprogeterone acetate · Drug: 17-b-estradiol hemihydrate · Drug: placebo pill + gel
Postmenopausal women without vasomotor symptoms
Drug: 17-b-estradiol · Drug: 17-b-estradiol + medroxyprogeterone acetate · Drug: 17-b-estradiol hemihydrate · Drug: placebo pill + gel
2mg oral daily for 6 months
2mg E2 + 5mg MPA daily for 6 months
Also known as: Indivina
1 mg skin gel daily for 6 months
Also known as: Divigel
placebo daily for 6 months
Vascular function
Time frame: 0 and 6 months
Cardiac and sympathetic function
Time frame: 0 and 6 months
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of Helsinki