Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 主要终点
- Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
研究概览
简要总结
The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.
详细描述
In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.
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
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese patients with PCOS
排除标准
- •Other causes of hyperandrogenism and
- •Use of drugs including:
- •oral contraceptive
- •anti-hypertensive agents
- •anti-diabetic drugs
- •agents for weight loss
研究组 & 干预措施
Metformin
850 mg/day twice a day
干预措施: Metformin (Drug)
Metformin plus spironolactone
Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
干预措施: Metformin plus Spironolactone (Drug)
结局指标
主要结局
Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
时间窗: six months
We evaluated metabolic parameters across anthropometric parameters: height, weight, waist circumference, BMI, glycemia, lipid profile, blood count, coagulation parameters, hepatic and renal function indexes, OGTT and HOMA-IR. The diagnosis of MetS was established according to the ATPIII criteria
次要结局
- Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome(six months)
研究者
Prof Antonino Belfiore
Full Professor
University Magna Graecia