NCT02984722Unknown不适用
Extended-release vs Immediate-release Metformin in PCOS Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Gastro intestinal disorders
研究概览
简要总结
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •women with PCOS in accordance with Rotterdam criteria
排除标准
- •pregnancy
- •diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- •past history of cardiovascular diseases
- •past history of gastro-intestinal diseases
- •significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
- •neoplasms.
研究组 & 干预措施
1
Experimental
PCOS women treated with 1500 mg/die of extended-release metformin
干预措施: Metformin (Drug)
2
Experimental
PCOS women treated with 1500 mg/die of immediate-release metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Gastro intestinal disorders
时间窗: 6 months
次要结局
- testosterone levels(6 months)
- free androgen index(6 months)
- total cholesterol(6 months)
- dheas levels(6 months)
- tryglycerides levels(6 months)
- number of cycles in 6 months of therapy(6 months)
- insulin levels(6 months)
- hirsutism score(6 months)
- androstenedione levels(6 months)
- ovarian volume(6 months)
研究者
Rosanna Apa
Professor
Catholic University of the Sacred Heart
研究点 (1)
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