A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Brachial Artery Flow-mediated Dilation (FMD)
研究概览
简要总结
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
详细描述
The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with PCOS
- •8 or fewer menstrual periods per year
- •elevated serum total testosterone
- •elevated LDL cholesterol
排除标准
- •current pregnancy or breastfeeding
- •current use of oral contraceptives, progestins
- •insulin sensitizing medications
- •thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
研究组 & 干预措施
Atorvastatin
干预措施: Lipitor (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Brachial Artery Flow-mediated Dilation (FMD)
时间窗: baseline and 6 weeks
Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.
次要结局
- Peak Brachial Artery Conductance (BAC)(baseline and 6 weeks)
- Total Cholesterol(baseline and 6 weeks)
- LDL Cholesterol(baseline and 6 weeks)
- HDL Cholesterol(baseline and 6 weeks)
- Triglycerides(baseline and 6 weeks)
- Fasting Glucose(baseline and 6 weeks)
- Fasting Insulin(baseline and 6 weeks)
- Area Under the Curve (AUC) for Glucose During OGTT(baseline and 6 weeks)
- AUC for Insulin(baseline and 6 weeks)
- Total Testosterone(baseline and 6 weeks)
- Androstenedione(baseline and 6 weeks)
- DHEAS(baseline and 6 weeks)
研究者
Richard S. Legro, M.D.
Professor, Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center