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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02161614

Acronym

VEDILA

Enrollment

Registered

2014-06-12

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2016-01-15

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

Conditions

Flow-mediated Dilation Evaluation of the Brachial Artery

Keywords

hormone replacement therapy, Dopplervelocimetry, Flow-mediated dilation, menopause, Estradiol valerate

Brief 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.

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 estradiol valerate on flow-mediated dilation of the brachial artery.

Interventions

DRUGEstradiol valerate

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Flow-mediated dilation of the brachial artery	30 days after treatment started

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026