Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Flow Mediated Vasodilation Microvascular skin blood flow analysis
研究概览
简要总结
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
详细描述
Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking, all subjects have endometriosis
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young women between the ages of 18 and 45 years (Controls);
- •Young women between the ages of 18 and 45 years with endometriosis.
排除标准
- •Subjects who smoke
- •Subjects who have diabetes,
- •Subjects with sleep apnea or BP>140/90 will be excluded.
- •Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
研究组 & 干预措施
patients without endometriosis
Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis
干预措施: Elagolix (Drug)
patients with endometriosis
Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor.
干预措施: Elagolix (Drug)
结局指标
主要结局
Flow Mediated Vasodilation Microvascular skin blood flow analysis
时间窗: 2 minutes
Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system.
Microdialysis perfusions
时间窗: 15 minutes
Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF).
次要结局
未报告次要终点