Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Study Overview
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Brief Summary
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The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Detailed Description
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The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial artery.

Official Title
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Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.

Conditions
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Unspecified Injury of Brachial Artery, Left Side, Initial Encounter

Intervention / Treatment
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* Drug: Estrogens, Conjugated (USP)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women without menstrual cycles within the last 12 months and FSH > 30IU/L Healthy women Women that were not using drugs with potential vascular effect within the last 1 year Women that never used hormone replacement therapy Exclusion Criteria: Smoking Blood Pressure > 160/90 mm Hg. Breast and or endometrial cancer History of acute myocardial infarction Diabetes Vaginal bleeding of any origin Hepatic disease Thrombophlebitis or thromboembolic disorders

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estrogen use<br>climacteric women will use conjugated equine estrogens | Drug: Estrogens, Conjugated (USP)<br>* Experimental group will use 0.625mg/day during 30 days<br>* Other names: Premarin;|
| Placebo Comparator: use of Placebo<br>climacteric women will use placebo | Drug: Placebo<br>* Placebo group will use placebo once/day during 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation of the brachial artery | Flow-mediated dilation will be measured by high resolution ultrasound | one month after treatment started | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone replacement therapy, Doppler velocimetry, Flow-mediated dilation, menopause