Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma concentration of metformin
研究概览
简要总结
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment.
However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
详细描述
Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
- •PCOS diagnosis.
- •Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.
排除标准
- •Another diseases with androgen excess;
- •Patients with history of serious adverse reaction or hypersensibility to any medicine;
- •History or presence of renal, hepatic or gastrointestinal disorders.
- •Continuous use of any pharmaco, inclusively metformin
研究组 & 干预措施
Metformin
study parallel with one arm only.
干预措施: Metformin (Drug)
结局指标
主要结局
Plasma concentration of metformin
时间窗: First day after administration until 3 months after begining of treatment
Blood samples are collected from each patient and the plasma concentration is analysed.
次要结局
- Number of adverse events(observation during 3 months of treatment)