Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery (EDILA)

August 13, 2014 updated by: Selmo Geber, Federal University of Minas Gerais

Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.

The aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 conjugated equine estrogen on flow-mediated dilation of the brachial artery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130100
        • Hospital das Clínicas - Universidade Federal de Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Estrogen use
climacteric women will use conjugated equine estrogens
Drug: Estrogens, Conjugated (USP)
Experimental group will use 0.625mg/day during 30 days
Other Names:
  • Premarin
Placebo Comparator: use of Placebo
climacteric women will use placebo
Drug: Placebo
Placebo group will use placebo once/day during 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated dilation of the brachial artery
Time Frame: one month after treatment started
Flow-mediated dilation will be measured by high resolution ultrasound
one month after treatment started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Selmo Geber, MD PhD, Medical School of Universidade Federal de Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 27, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.FR - 245365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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