Vascular Effect of Estrogens Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
EDILA
Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 27, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 15, 2014
August 1, 2014
2.8 years
November 27, 2011
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilation of the brachial artery
Flow-mediated dilation will be measured by high resolution ultrasound
one month after treatment started
Study Arms (2)
Estrogen use
EXPERIMENTALclimacteric women will use conjugated equine estrogens
use of Placebo
PLACEBO COMPARATORclimacteric women will use placebo
Interventions
Experimental group will use 0.625mg/day during 30 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100, Brazil
Related Publications (2)
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.
PMID: 21471823BACKGROUNDHurtado R, Celani M, Geber S. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial. Climacteric. 2016 Oct;19(5):448-51. doi: 10.1080/13697137.2016.1201809. Epub 2016 Jul 16.
PMID: 27427235DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selmo Geber, MD PhD
Medical School of Universidade Federal de Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2011
First Posted
November 30, 2011
Study Start
November 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 15, 2014
Record last verified: 2014-08