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Vascular Effect of Tibolone in the Brachial Artery (TDILA)

This study is currently recruiting participants.
Verified September 2012 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01543399
First received: February 21, 2012
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies the investigators showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial artery.


Condition Intervention
Menopause
 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
Official Title: Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    We will evaluate the vascular effect of Tibolone on the brachial artery. The diameter of the artery will be measured before and one month after use of Tibolone and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.


Secondary Outcome Measures:
  • Patients symptoms before and after the use of Tibolone [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tibolone use
climacteric women will use Tibolone for 30 days
 Drug: Tibolone
Experimental group will use 2.5mg of tibolone for 30 days
Other Name: Livial
Placebo Comparator: Placebo use
climacteric women will use placebo for 30 days
 Drug: Placebo
patients of the placebo group will use placebo one a day for 30 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women without menstrual cycles within the last 12 months and FSH > 30IU/L
  • Healthy women
  • Women that were not using drugs with potential vascular effect within 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543399

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 34099304     myriancelani@gmail.com    
Principal Investigator: Selmo Geber, MD PhD            
Sub-Investigator: Myrian Celani, MD            
Sponsors and Collaborators
Selmo Geber
Investigators
Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
  More Information

Publications:

Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01543399     History of Changes
Other Study ID Numbers: T.FR - 245365, ETIC0417
Study First Received: February 21, 2012
Last Updated: September 5, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of Minas Gerais:
Tibolone
climacteric
Doppler
hormone replacement therapy

Additional relevant MeSH terms:
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Tibolone
Androgen Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents

ClinicalTrials.gov processed this record on May 22, 2013