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临床试验/NCT01798875
NCT01798875Unknown4 期

Effects of Different Therapies on Surrogate Markers of Cardiovascular Risk in Women With Polycystic Ovary Syndrome (PCOS)

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
试验地点
1
主要终点
serum C-reactive protein (CRP) levels

研究概览

简要总结

In addition to chronic anovulation and hyperandrogenemia, polycystic ovary syndrome (PCOS) is also characterized by peripheral insulin resistance and hyperinsulinaemia, which in turn lead to the development of diabetes, hypertension, atherosclerosis and coronary heart disease. Serum markers of inflammation are being increasingly recognized as predictors of atherosclerosis and cardiovascular risk, and chronic low-grade inflammation has been recently proposed to play a role in the pathogenesis of metabolic syndrome and type 2 diabetes mellitus. Therefore, the aim of the present study is to evaluate the effects of commonly used non-pharmacologic (diet and lifestyle change) and pharmacologic (oral contraceptives, metformin, anti-androgens) treatment strategies on classical and surrogate cardiovascular risk markers in women with PCOS. The study hypothesis is that some of the commonly used therapies of women with PCOS may have more favorable effects on classical and surrogate markers of cardiovascular risk then others or some of them may even confer a higher risk of cardiovascular events

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • pregnancy
  • contraindications to oral contraceptives

研究组 & 干预措施

Metformin

Active Comparator

oral metformin at a dose of 850mg twice daily

干预措施: oral metformin (Drug)

Oral contraceptive

Active Comparator

oral contraceptive containing 35ug of ethynylestradiol and 2mg of cyproterone acetate (21 day regimen)

干预措施: oral contraceptive (Drug)

结局指标

主要结局

serum C-reactive protein (CRP) levels

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominik Rachon

M.D. PhD

Medical University of Gdansk

研究点 (1)

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