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

Unspecified Injury of Brachial Artery, Left Side, Initial Encounter Clinical Trial

— EDILA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482416
• Other study ID #: E.FR - 245365
• Status: Completed
• Phase: N/A
• First received: November 27, 2011
• Last updated: August 13, 2014
• Start date: November 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• 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 estrogens 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 conjugated equine estrogen on flow-mediated dilation of the brachial artery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women without menstrual cycles within the last 12 months and FSH > 30IU/L

• 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

• Unspecified Injury of Brachial Artery, Left Side, Initial Encounter

Intervention

Drug:
• Estrogens, Conjugated (USP)
Experimental group will use 0.625mg/day during 30 days
• Placebo
Placebo group will use placebo once/day during 30 days

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, 

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	Flow-mediated dilation will be measured by high resolution ultrasound	one month after treatment started	No