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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01679795
First received: September 3, 2012
Last updated: June 8, 2014
Last verified: June 2014
  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
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


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   50 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679795

Contacts
Contact: Selmo Geber, MD PhD 55 31 34099304 sjgeber@terra.com.br
Contact: Myrian Celani, MD 55 31 34099764 myriancelani@gmail.com

Locations
Brazil
hospital das Clinicas - Universidade Federal de Minas Gerais Recruiting
belo Horizonte, minas Gerais, Brazil, 30130100
Contact: selmo geber, MD PhD    55 31 34099304    sjgeber@terra.com.br   
Contact: myrian celani, mD    55 31 34099664    myriancelani@gmail.com   
Principal Investigator: Selmo Geber, MD PhD         
Sponsors and Collaborators
Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01679795     History of Changes
Other Study ID Numbers: TDILA
Study First Received: September 3, 2012
Last Updated: June 8, 2014
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:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Tibolone
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones

ClinicalTrials.gov processed this record on August 01, 2014