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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482416
First Posted: November 30, 2011
Last Update Posted: August 15, 2014
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.
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Selmo Geber, Federal University of Minas Gerais:

Primary Outcome Measures:
  • Flow-mediated dilation of the brachial artery [ Time Frame: one month after treatment started ]
    Flow-mediated dilation will be measured by high resolution ultrasound


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: August 2014
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes 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
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): NCT01482416


Locations
Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: November 27, 2011
First Posted: November 30, 2011
Last Update Posted: August 15, 2014
Last Verified: August 2014

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

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