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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679795
First Posted: September 6, 2012
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Selmo Geber, 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 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679795


Locations
Brazil
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
ClinicalTrials.gov Identifier: NCT01679795     History of Changes
Other Study ID Numbers: TDILA
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: April 3, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Tibolone
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones