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

Federal University of Minas Gerais

Status: Completed

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

Treatments: Drug: Estrogens, Conjugated (USP); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01482416

E.FR - 245365

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Estrogen use

Experimental group

Description:

climacteric women will use conjugated equine estrogens

Treatment:

Drug: Estrogens, Conjugated (USP)

use of Placebo

Placebo Comparator group

Description:

climacteric women will use placebo

Treatment:

Drug: Placebo