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

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.
 
ClinicalTrials.gov Identifier: NCT01679795
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Flow-mediated Dilation Evaluation of the Brachial Artery Drug: Tibolone Drug: Placebo Not Applicable

Study Design
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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
Study Start Date : February 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older 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
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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
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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
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Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01679795    
Other Study ID Numbers: TDILA
First Posted: September 6, 2012    Key Record Dates
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:
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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