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

Not Applicable

Completed

• Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery
• Interventions: Drug: Placebo; Drug: Estradiol valerate

• Registration Number: NCT02161614
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will use placebo for 30 days
Estradiol Valerate	Estradiol valerate	patients will use estradiol valerate 1mg/day during 30 days

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation of the brachial artery	30 days after treatment started

Trial Locations

Locations (1)

Hospital das Clinicas - Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil