Estrogen Therapy as Prevention in the Progression of Aneurysm
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effect of low dose estradiol on a panel of serum markers.
研究概览
简要总结
This study aims to determine if hormone replacement therapy, given during perimenopause may prevent the progression of saccular cerebral aneurysms.
详细描述
This is a prospective, randomized, placebo-control trial to test the effect of estradiol in the prevention of progression of cerebral aneurysms. To evaluate the effect, each subject will be treated with either oral estradiol or placebo for 6 months. Subjects will be randomly assigned to 1 of 2 groups as follows:
Double Blind Treatment Group Open-Label Regimen A1 1 mg Estradiol daily for 180 days B1 Placebo for 180 days
Each group will be given oral Progesterone (3300 mg) for 10 days at the end of 90 days regardless of menstrual pattern. Subjects will be asked to keep a menstrual calendar throughout the trial. Serum markers will be drawn at baseline and every 90 days with the results blinded until the end of the trial. Magnetic resonance angiography (MRA) studies of the brain will be performed at month 6.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy women, 40-52 years of age.
- •At least one documented saccular intracranial cerebral aneurysm detected via catheter angiography, magnetic resonance angiography or computed tomography angiography.
- •Clinical diagnosis of perimenopause, defined as regular or irregular menses with or without vasomotor symptoms.
排除标准
- •Known or suspected estrogen-dependent neoplasia.
- •Endometrial proliferation, hyperplasia, or malignancy at screening.
- •Known hypersensitivity to estrogens, progestins.
- •History of myocardial infarction, ischemic heart disease, lipid disorder, or congestive heart failure.
- •Known or suspected pregnancy, or recent breast feeding (within 6 months).
研究组 & 干预措施
Estradiol Daily
1 mg Estradiol daily for 180 days.
干预措施: Estradiol (Drug)
Placebo
Placebo for 180 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of low dose estradiol on a panel of serum markers.
时间窗: Change in levels of serum markers from baseline and six months.
Parallel design double-blind placebo controlled trial to assess the effect of low dose estradiol on serum lipoprotein (a), serum elastase, and homocysteine.
次要结局
- Radiographic change in the cerebral vasculature after treatment.(From date of randomization to six months.)
研究者
Michael Chen, M.D.
Associate Professor of Neurology, Neurosurgery and Radiology
Rush University Medical Center