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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2015

Interventions

  • Drug: Tibolone
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Tibolone
    • patientes will use tibolone 2,5mg/day during 30 days
  • Placebo Comparator: Placebo use
    • Patients will use placebo for 30 days

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 30 days
    • Flow-mediated dilation will be measured by high resolution ultrasound

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Selmo Geber, Associate Professor – Federal University of Minas Gerais

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