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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01482416

Acronym

EDILA

Enrollment

Registered

2011-11-30

Start date

2011-11-30

Completion date

2014-08-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Injury of Brachial Artery, Left Side, Initial Encounter

Keywords

hormone replacement therapy, Doppler velocimetry, Flow-mediated dilation, menopause

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.

Interventions

DRUGEstrogens, Conjugated (USP)

Experimental group will use 0.625mg/day during 30 days

DRUGPlacebo

Placebo group will use placebo once/day during 30 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Flow-mediated dilation of the brachial artery	one month after treatment started	Flow-mediated dilation will be measured by high resolution ultrasound

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026