Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Flow-mediated dilation of the brachial artery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Patients will use placebo for 30 days
干预措施: Placebo (Drug)
Estradiol Valerate
patients will use estradiol valerate 1mg/day during 30 days
干预措施: Estradiol valerate (Drug)
结局指标
主要结局
Flow-mediated dilation of the brachial artery
时间窗: 30 days after treatment started
次要结局
未报告次要终点
研究者
Selmo Geber
Professor
Federal University of Minas Gerais