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Vascular Effect of Tibolone in the Brachial Artery (TDILA)

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ClinicalTrials.gov Identifier: NCT01543399
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Brief Summary:
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 or disease Intervention/treatment
Menopause Drug: Tibolone Drug: Placebo

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Study Start Date : March 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone. [ Time Frame: 30 days ]
    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 :
  1. Patients symptoms before and after the use of Tibolone [ Time Frame: 30 days ]


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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes 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

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): NCT01543399


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

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 ( Other Identifier: ethics committee )
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
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