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临床试验/NCT02689843
NCT02689843已完成早期 1 期

Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Serum C3 level

研究概览

简要总结

The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.

详细描述

Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.

Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.

The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Age 18-35 years
  • Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
  • Oligomenorrhea or anovulation
  • Clinical and/or biochemical signs of hyperandrogenism
  • Polycystic ovaries (by ultrasound)

排除标准

  • Pregnancy
  • Diabetes mellitus
  • Renal failure (serum creatinine >1.5)
  • Congenital adrenal hyperplasia
  • Hyper or hypothyroidism
  • Sex hormone therapy or antiandrogen therapy during the last three months
  • Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above normal range
  • Any systemic or febrile illnesses
  • Use of glucocorticoid or anti-inflammatory drugs during the last three months
  • Androgen secreting tumor
  • Malignancy

研究组 & 干预措施

Cyproterone compound + Spironolactone

Active Comparator

Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily

干预措施: Cyproterone compound + Spironolactone (Drug)

Metformin

Active Comparator

Metformin 1500 mg daily

干预措施: Metformin (Drug)

Pioglitazone

Active Comparator

Pioglitazone 30 mg daily

干预措施: Pioglitazone (Drug)

结局指标

主要结局

Serum C3 level

时间窗: 3 months

Serum concentration of a component of complement cascade: C3

Serum high-sensitive CRP (C-reactive protein)

时间窗: 3 months

Serum concentration of high-sensitive C-reactive protein (hs-CRP)

Serum C4 level

时间窗: 3 months

Serum concentration of a component of complement cascade: C4

次要结局

  • Serum free Testosterone level(3 months)
  • Serum luteinizing hormone (LH) level(3 months)
  • Serum Dehydroepiandrosterone sulfate (DHEAS) level(3 months)
  • Serum homocysteine level(3 months)
  • Serum total Testosterone level(3 months)
  • Serum follicle stimulating hormone (FSH) level(3 months)
  • Fasting Serum Insulin level(3 months)
  • Number of patients with adverse events(3 months)
  • Fasting Blood Sugar (FBS)(3 months)

研究者

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

Mesbah Shams, MD

Associate professor of internal medicine and endocrinology

Shiraz University of Medical Sciences

研究点 (1)

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