Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.
详细描述
In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism and presence of > 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group , metformin was administered for patients 1500 mg daily for three months. In orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI>= 30
排除标准
- •Drug use during last three months
研究组 & 干预措施
Orlistat
The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
干预措施: orlistat (Drug)
Metformin
The dose of metformin was increased step - wise, from 500 mg once daily for the first week to 500 mg twice daily for the next week, and to 500 mg three times daily for the remaining study period .
干预措施: orlistat (Drug)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 3 months
次要结局
- Ovulatory(3 months)
研究者
Nasim Tabibnejad
Dr.
Yazd Research & Clinical Center for Infertility