Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
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
- Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone.
研究概览
简要总结
The interruption of the secretion of sex steroids occurring during menopause, causes a change in vascular pattern at various levels. As a result, several agencies have side effects that interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies the investigators showed the effect of sex steroids in premenopausal women in the conjugated equine estrogens, medroxyprogesterone acetate and tibolone in menopausal women, on the central retinal arteries. The aim of this study is to evaluate the effects of Tibolone in Flow-Mediated Dilatation of the brachial artery.
详细描述
Menopause is a transitional phase of the biological evolution of women where there is loss of reproductive capacity. The phenomena are the most striking manifestations represented by vasomotor hot flushes and sweating, the consequent fall in estradiol production by the ovaries. The main landmark of the menopause is menopause, which is the last period governed by the ovaries, reflecting the depletion of the same follicle.
The main clinical manifestations of the climacteric are vascular, acting through mechanisms of action not fully understood. Several studies were published showing its effect on vasomotor tone and demonstrating the production of vasoactive substances by vascular cells induced by them.
The main objective of HRT (Hormone Replacement Therapy), is to improve the physical and psychological state of women who have climacteric disorders, leading to improved quality of life. The American College of Physicians, after careful review of available evidence, it is recommended that all postmenopausal women should be considered eligible to receive HRT and that the decision to treat or not should be individualized. Besides the knowledge of the pattern of endocrine patients climate, the investigators must subject it to full physical examination (pelvic) and exams before planning to start HRT. Complementary tests must be clinically oriented, respecting the resources available. There is no need to make routine use of doses of gonadotropins and sex steroids, which are reserved for certain diagnostic situations where there is any doubt, for example, premature ovarian failure syndrome.
He is currently a world consensus that the best available treatment for menopause is hormone replacement therapy because exogenously resets once the hormones produced by the ovaries. HRT fulfills several objectives: reverse neurovegetative symptoms, improves trophism genital atrophy and genital-urinary, acts in the prevention and treatment of osteoporosis, leading to lower incidence of colorectal cancer, promotes a later onset, lower incidence, evolution and improvement in symptoms of Alzheimer's disease has a positive influence on the view.
The development of HRT and the results that prove their individual benefits and epidemiological brought new questions about the most appropriate way to use the various schemes available. The treatment regimens are designed to establish a hormonal profile similar to that of premenopausal using: estrogens, progestogens and androgens in different doses and routes of administration.
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
- 45 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 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
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
Tibolone use
climacteric women will use Tibolone for 30 days
干预措施: Tibolone (Drug)
Placebo use
climacteric women will use placebo for 30 days
干预措施: Placebo (Drug)
结局指标
主要结局
Diameter measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of tibolone.
时间窗: 30 days
We will evaluate the vascular effect of Tibolone on the brachial artery. The diameter of the artery will be measured before and one month after use of Tibolone and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.
次要结局
- Patients symptoms before and after the use of Tibolone(30 days)
研究者
Selmo Geber
Associate Professor
Federal University of Minas Gerais
