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

This study has been completed.
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais Identifier:
First received: September 3, 2012
Last updated: April 2, 2015
Last verified: April 2015
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.

Condition Intervention
Flow-mediated Dilation Evaluation of the Brachial Artery
Drug: Tibolone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    Flow-mediated dilation will be measured by high resolution ultrasound

Enrollment: 60
Study Start Date: February 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibolone
patientes will use tibolone 2,5mg/day during 30 days
Drug: Tibolone
Other Name: Livial
Placebo Comparator: Placebo use
Patients will use placebo for 30 days
Drug: Placebo


Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01679795

hospital das Clinicas - Universidade Federal de Minas Gerais
belo Horizonte, minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
  More Information

Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais Identifier: NCT01679795     History of Changes
Other Study ID Numbers: TDILA 
Study First Received: September 3, 2012
Last Updated: April 2, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Minas Gerais:
hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone

Additional relevant MeSH terms:
Anabolic Agents
Androgen Antagonists
Antihypertensive Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 24, 2016