The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Androgen secretion
研究概览
简要总结
This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS.
We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.
详细描述
30 women diagnosed for PCOS (aged 30-50 years) are enrolled for the study. 15 women are randomized in the atorvastatin group and 15 in the placebo group. The women with PCOS participating in the study are required to use safe non-hormonal contraception during the medication.
The study includes transvaginal ultrasonography, serum samples, oral glucose tolerance test (OGTT) and intra venous tolerance test (IVGTT) before and after receiving 6 months atorvastatin 20mg/day therapy or placebo.
Measurements for androgen levels, pituitary hormones, glucose, insulin and inflammatory markers are performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed for PCOS (Rotterdam criteria)
- •aged 30-50 years
- •safe non-hormonal contraception
排除标准
- •use of cholesterol lowering agents
- •use of antidepressants
- •use of cortisone medication (p.o.)
- •use of hormonal contraception
- •pregnancy
- •liver disease
- •menopause
- •kidney or liver failure
研究组 & 干预措施
Atorvastatin
6 months atorvastatin 20mg/day treatment
干预措施: Atorvastatin (Drug)
Placebo
6 months placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Androgen secretion
时间窗: 0, 3, 6 months
Glucose metabolism
时间窗: 0, (3), 6 months
次要结局
- Inflammatory markers(0, 3, 6 months)