NCT00564031已完成3 期
Hormonal Replacement Therapy and Small Artery Function
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- endothelium-dependent dilatation
研究概览
简要总结
Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease
详细描述
We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women had been amenorrheic for at least 1.5 year.
- •Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH > 34 IU/ml) and estradiol (E2 <50 pmol/l).
排除标准
- •Cigarette smokers and women with:
- •Hypertension
- •Diabetes mellitus
- •Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease)
- •Venous thromboembolic disease
- •Liver disorders
- •Unexplained vaginal bleeding; and
- •Personal or family history of breast cancer were excluded.
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Experimental
干预措施: Femanest (Drug)
3
Experimental
干预措施: gestapuran (Drug)
4
Experimental
干预措施: Femanest plus Gestapuran (Drug)
结局指标
主要结局
endothelium-dependent dilatation
时间窗: 3 month
次要结局
- pressure-induced tone and vascular morphology(3 month)
研究者
研究点 (1)
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