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

Flow-mediated Dilation Evaluation of the Brachial Artery Clinical Trial

— VEDILA  

Official title:

Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161614
• Other study ID #: DILA V E2
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: January 14, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the vascular effects of estradiol valerate on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

Description:

The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)>30International Units / Liter

• Healthy women

• Women that were not using drugs with potential vascular effect within 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:
• Estradiol valerate

• Placebo

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Faria AF, de Souza MA, Geber S. Vascular resistance of central retinal artery is reduced in postmenopausal women after use of estrogen. Menopause. 2011 Aug;18(8):869-72. doi: 10.1097/gme.0b013e31820cc60c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation of the brachial artery		30 days after treatment started	Yes