NCT07077395招募中2 期
Finding Links Between Hot flASHes and CardioVascular Disease
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- brachial artery flow mediated dilation
研究概览
简要总结
The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •Peri- and post-menopausal women (STRAW -1 to +1)
- •Moderate or high vasmotor symptom burden
- •Cardiometabolic disease (as evidenced by ≥ 2 of the following):
- •Obesity (body mass index ≥ 30 kg/m2)
- •Elevated waist circumference (≥ 88 cm)
- •Elevated triglycerides (≥ 150 mg/dL or drug treatment)
- •Reduced HDL-cholesterol (<50 mg/dL or drug treatment)
- •Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment)
- •Elevated fasting glucose (≥ 100 mg/dL or drug treatment)
排除标准
- •Inability to provide informed consent or comply with study protocol
- •Major comorbidities: cancer, end-stage renal (eGFR <45 mL/min/1.73 m2), liver or lung disease
- •Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors
- •Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)
- •Undiagnosed uterine bleeding over past 6 months
研究组 & 干预措施
elinzanetant 120 mg daily for 12 weeks
Active Comparator
干预措施: elinzanetant - reference formulation (Drug)
Placebo daily for 12 weeks
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
brachial artery flow mediated dilation
时间窗: 12 weeks
次要结局
- concentration of inflammatory protein biomarkers(12 weeks)
研究者
Emily Lau
Principal Investigator
Massachusetts General Hospital
研究点 (2)
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