Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

Federal University of Minas Gerais

Status: Completed

Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery

Treatments: Drug: Tibolone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01679795

TDILA

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Tibolone

Experimental group

Description:

patientes will use tibolone 2,5mg/day during 30 days

Treatment:

Drug: Tibolone

Placebo use

Placebo Comparator group

Description:

Patients will use placebo for 30 days

Treatment:

Drug: Placebo