Vascular Effect of Estradiol Valerate 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 estradiol valerate 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 estradiol valerate 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 Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.

Conditions
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Flow-mediated Dilation Evaluation of the Brachial Artery

Intervention / Treatment
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* Drug: Estradiol valerate
* 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 follicle stimulating hormone (FSH)>30International Units / Liter 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: 50 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will use placebo for 30 days | Drug: Placebo<br> <br> |
| Experimental: Estradiol Valerate<br>patients will use estradiol valerate 1mg/day during 30 days | Drug: Estradiol valerate<br> <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 |  | 30 days 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, Dopplervelocimetry, Flow-mediated dilation, menopause, Estradiol valerate