Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery (VEDILA)

Federal University of Minas Gerais

Status: Completed

Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery

Treatments: Drug: Estradiol valerate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02161614

DILA V E2

Details and patient eligibility

About

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.

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 estradiol valerate on flow-mediated dilation of the brachial artery.

Enrollment: 60 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

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

Placebo

Placebo Comparator group

Description:

Patients will use placebo for 30 days

Treatment:

Drug: Placebo

Estradiol Valerate

Experimental group

Description:

patients will use estradiol valerate 1mg/day during 30 days

Treatment:

Drug: Estradiol valerate