Vascular Effect of Tibolone in the Brachial Artery (TDILA)

This study has been completed.
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais Identifier:
First received: February 21, 2012
Last updated: April 2, 2015
Last verified: April 2015
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
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:

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 ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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


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

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
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Please refer to this study by its identifier: NCT01543399

hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Selmo Geber
Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais
  More Information

Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais Identifier: NCT01543399     History of Changes
Other Study ID Numbers: T.FR - 245365, ETIC0417
Study First Received: February 21, 2012
Last Updated: April 2, 2015
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Anabolic Agents
Androgen Antagonists
Antihypertensive Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015