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

April 2, 2015 updated by: Selmo Geber, Federal University of Minas Gerais
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • minas Gerais
      • belo Horizonte, minas Gerais, Brazil, 30130100
        • Hospital das Clínicas - Universidade Federal de Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tibolone
patientes will use tibolone 2,5mg/day during 30 days
Drug: Tibolone
Other Names:
  • Livial
Placebo Comparator: Placebo use
Patients will use placebo for 30 days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDILA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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