A Phase 4 interventional study of Estrogen in Postmenopausal Symptoms, sponsored by Rio de Janeiro State University. Completed at 1 site in Brazil. Open to female participants aged 48 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-04-18.
Sponsored by Rio de Janeiro State University · Phase 4, Interventional, and Treatment
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.
Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.
The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.
Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo (transdermal gel)
Drug: Estrogen
1mg of 17B-estradiol/day (transdermal gel)
Drug: Estrogen
transdermal 17-β-estradiol 1mg/day during three months
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
Time frame: 03 months
blood viscosity(the values are expressed in centipoises)
evaluate the change in blood viscosity after 3 months of treatment
Time frame: 03 months
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Rio de Janeiro State University