Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
VEDILA
Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate 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 estradiol valerate 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 Feb 2014
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 15, 2016
January 1, 2016
1.8 years
June 10, 2014
January 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilation of the brachial artery
30 days after treatment started
Study Arms (2)
Placebo
PLACEBO COMPARATORPatients will use placebo for 30 days
Estradiol Valerate
EXPERIMENTALpatients will use estradiol valerate 1mg/day during 30 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
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 (1)
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: 21471823BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selmo Geber, MD PhD
Federal University of 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
- Professor
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 12, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 15, 2016
Record last verified: 2016-01