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

NCT ID: NCT01482416

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-08-31

Brief 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.

Detailed 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.

Conditions

Unspecified Injury of Brachial Artery, Left Side, Initial Encounter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Estrogen use

climacteric women will use conjugated equine estrogens

Group Type: EXPERIMENTAL

Estrogens, Conjugated (USP)

Intervention Type: DRUG

Experimental group will use 0.625mg/day during 30 days

use of Placebo

climacteric women will use placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo group will use placebo once/day during 30 days

Interventions

Estrogens, Conjugated (USP)

Experimental group will use 0.625mg/day during 30 days

Intervention Type: DRUG

Placebo

Placebo group will use placebo once/day during 30 days

Intervention Type: DRUG

Other Intervention Names

Premarin

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Selmo Geber

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selmo Geber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical School of Universidade Federal de Minas Gerais

Locations

Hospital das Clinicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 21471823 (View on PubMed)

Hurtado R, Celani M, Geber S. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial. Climacteric. 2016 Oct;19(5):448-51. doi: 10.1080/13697137.2016.1201809. Epub 2016 Jul 16.

Reference Type: DERIVED

PMID: 27427235 (View on PubMed)

Other Identifiers

E.FR - 245365

Identifier Type: -

Identifier Source: org_study_id