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

Federal University of Minas Gerais60 enrolled

Overview

The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Flow-mediated Dilation Evaluation of the Brachial Artery

Interventions

TiboloneDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women without menstrual cycles whithin the last 12 months and FSH\>30IU/L * Healthy women * Women that were not using drugs with potential vascular effect whithin 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

Locations (1)

hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery

Flow-mediated dilation will be measured by high resolution ultrasound

Time frame: 30 days

Data from ClinicalTrials.gov

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