Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- testosterone serum concentration
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.
This study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.
Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •insulin resistance
- •normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
排除标准
- •use of oral contraceptives and/or other steroid hormones 3 months prior to the study
研究组 & 干预措施
Simvastatin + resveratrol
simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
干预措施: Simvastatin and micronized trans-resveratrol (Drug)
simvastatin+ placebo
simvastatin 20 mg daily Placebo
干预措施: Simvastatin and micronized trans-resveratrol (Drug)
结局指标
主要结局
testosterone serum concentration
时间窗: 2 years
次要结局
未报告次要终点
研究者
Beata Banaszewska
MD PhD Ass Professor
Poznan University of Medical Sciences