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

Primary Purpose

Flow-mediated Dilation Evaluation of the Brachial Artery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tibolone
Placebo
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flow-mediated Dilation Evaluation of the Brachial Artery focused on measuring hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • hospital das Clinicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tibolone

Placebo use

Arm Description

patientes will use tibolone 2,5mg/day during 30 days

Patients will use placebo for 30 days

Outcomes

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
Flow-mediated dilation will be measured by high resolution ultrasound

Secondary Outcome Measures

Full Information

First Posted
September 3, 2012
Last Updated
April 2, 2015
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01679795
Brief Title
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flow-mediated Dilation Evaluation of the Brachial Artery
Keywords
hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tibolone
Arm Type
Experimental
Arm Description
patientes will use tibolone 2,5mg/day during 30 days
Arm Title
Placebo use
Arm Type
Placebo Comparator
Arm Description
Patients will use placebo for 30 days
Intervention Type
Drug
Intervention Name(s)
Tibolone
Other Intervention Name(s)
Livial
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
Flow-mediated dilation will be measured by high resolution ultrasound
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
hospital das Clinicas - Universidade Federal de Minas Gerais
City
belo Horizonte
State/Province
minas Gerais
ZIP/Postal Code
30130100
Country
Brazil

12. IPD Sharing Statement

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

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