Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Flow-mediated dilation of the brachial artery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •Blood Pressure > 160/90 mm Hg.
- •Breast and or endometrial cancer
- •History of acute myocardial infarction
- •Vaginal bleeding of any origin
- •Hepatic disease
- •Thrombophlebitis or thromboembolic disorders
Arms & Interventions
Estrogen use
climacteric women will use conjugated equine estrogens
Intervention: Estrogens, Conjugated (USP) (Drug)
use of Placebo
climacteric women will use placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Flow-mediated dilation of the brachial artery
Time Frame: one month after treatment started
Flow-mediated dilation will be measured by high resolution ultrasound
Secondary Outcomes
No secondary outcomes reported
Investigators
Selmo Geber
Associate Professor
Federal University of Minas Gerais