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

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ClinicalTrials.gov Identifier: NCT02161614
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Flow-mediated Dilation Evaluation of the Brachial Artery Drug: Estradiol valerate Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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 Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Study Start Date : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will use placebo for 30 days
Drug: Placebo
Experimental: Estradiol Valerate
patients will use estradiol valerate 1mg/day during 30 days
Drug: Estradiol valerate



Primary Outcome Measures :
  1. Flow-mediated dilation of the brachial artery [ Time Frame: 30 days after treatment started ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02161614


Locations
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Brazil
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130100
Sponsors and Collaborators
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
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Principal Investigator: Selmo Geber, MD PhD Federal University of Minas Gerais

Publications:
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Responsible Party: Selmo Geber, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02161614     History of Changes
Other Study ID Numbers: DILA V E2
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Selmo Geber, Federal University of Minas Gerais:
hormone replacement therapy
Dopplervelocimetry
Flow-mediated dilation
menopause
Estradiol valerate
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Dilatation, Pathologic
Pathological Conditions, Anatomical
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female