Flow-mediated Dilation Evaluation of the Brachial Artery
Conditions
Keywords
hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
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.
Interventions
DRUGTibolone
DRUGPlacebo
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery one month after treatment started Flow-mediated dilation of the brachial artery | 30 days | Flow-mediated dilation will be measured by high resolution ultrasound |
Countries
Brazil
Outcome results
None listed