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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Federal University of Minas Gerais
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01482416
First received: November 27, 2011
Last updated: June 8, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Unspecified Injury of Brachial Artery, Left Side, Initial Encounter
Drug: Estrogens, Conjugated (USP)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Flow-mediated dilation of the brachial artery [ Time Frame: one month after treatment started ] [ Designated as safety issue: No ]
    Flow-mediated dilation will be measured by high resolution ultrasound


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Premarin
Placebo Comparator: use of Placebo
climacteric women will use placebo
Drug: Placebo
Placebo group will use placebo once/day during 30 days

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482416

Contacts
Contact: Selmo Geber, MD PhD 55 31 34099304 sjgeber@terra.com.br

Locations
Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130100
Contact: Rodrigo Hurtado, MD    55 31 34099304    rodrigo.hurtado@uol.com.br   
Sub-Investigator: Rodrigo Hurtado, MD         
Principal Investigator: Selmo Geber, MD PhD         
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Selmo Geber, MD PhD Medical School of Universidade Federal de Minas Gerais
  More Information

Publications:
Responsible Party: Selmo Geber, Associate Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01482416     History of Changes
Other Study ID Numbers: E.FR - 245365
Study First Received: November 27, 2011
Last Updated: June 8, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
hormone replacement therapy
Doppler velocimetry
Flow-mediated dilation
menopause

Additional relevant MeSH terms:
Wounds and Injuries
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014