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Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery (VEDILA)

Primary Purpose

Flow-mediated Dilation Evaluation of the Brachial Artery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Estradiol valerate
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, Estradiol valerate

Eligibility Criteria

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

Inclusion Criteria:

  • Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)>30International Units / Liter
  • 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

Sites / Locations

  • Hospital das Clinicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Estradiol Valerate

Arm Description

Patients will use placebo for 30 days

patients will use estradiol valerate 1mg/day during 30 days

Outcomes

Primary Outcome Measures

Flow-mediated dilation of the brachial artery

Secondary Outcome Measures

Full Information

First Posted
June 10, 2014
Last Updated
January 14, 2016
Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02161614
Brief Title
Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Acronym
VEDILA
Official Title
Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the vascular effects of estradiol valerate on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Detailed Description
The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.

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, Estradiol valerate

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
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will use placebo for 30 days
Arm Title
Estradiol Valerate
Arm Type
Experimental
Arm Description
patients will use estradiol valerate 1mg/day during 30 days
Intervention Type
Drug
Intervention Name(s)
Estradiol valerate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Flow-mediated dilation of the brachial artery
Time Frame
30 days after treatment started

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 within the last 12 months and follicle stimulating hormone (FSH)>30International Units / Liter 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selmo Geber, MD PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
21471823
Citation
Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c.
Results Reference
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Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

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