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

Flow-mediated Dilation Evaluation of the Brachial Artery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679795
• Other study ID #: TDILA
• Status: Completed
• Phase: N/A
• First received: September 3, 2012
• Last updated: April 2, 2015
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flow-mediated Dilation Evaluation of the Brachial Artery

Intervention

Drug:
• Tibolone

• Placebo

Locations

Country	Name	City	State
Brazil	hospital das Clinicas - Universidade Federal de Minas Gerais	belo Horizonte	minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Flow-mediated dilation will be measured by high resolution ultrasound	30 days	Yes