Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Not Applicable
Completed
- Conditions
- Flow-mediated Dilation Evaluation of the Brachial Artery
- Interventions
- Drug: Placebo
- Registration Number
- NCT01679795
- Lead Sponsor
- Federal University of Minas Gerais
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo use Placebo Patients will use placebo for 30 days Tibolone Tibolone patientes will use tibolone 2,5mg/day during 30 days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
hospital das Clinicas - Universidade Federal de Minas Gerais
🇧🇷belo Horizonte, minas Gerais, Brazil