Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)
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
- 否
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
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
Metformin 1500 mg daily
干预措施: Metformin (Drug)
Pioglitazone
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
Mesbah Shams, MD
Associate professor of internal medicine and endocrinology
Shiraz University of Medical Sciences
