Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
ClinicalTrials.gov ID
NCT01679795
Lead Sponsor
Federal University of Minas GeraisOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
60Actual
Last Update Posted
Apr 3, 2015Estimated
Start Date
Feb 2012
Primary Completion Date
Feb 2015Actual
Completion Date
Feb 2015Actual
Brief Summary
The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.
Flow-mediated Dilation Evaluation of the Brachial Artery
Tibolone
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Women without menstrual cycles whithin the last 12 months and FSH>30IU/L
Healthy women
Women that were not using drugs with potential vascular effect whithin 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
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
No central contacts
There are no central contacts for this study.
hospital das Clinicas - Universidade Federal de Minas Gerais