Combined Treatment With PDE-4 Inhibitor Roflumilast and Metformin Leads to Significant Weight Loss in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The main outcome was change in body weight.
研究概览
简要总结
The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old to menopause
- •polycystic ovary syndrome (NICHD criteria)
- •BMI of 30 kg/m² or higher
排除标准
- •depression
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •significant cardiovascular, kidney or hepatic disease
- •the use of medications other than metformin known or suspected to affect reproductive or metabolic functions
- •the use of statins, within 90 days prior to study entry
研究组 & 干预措施
metformin
In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os.
干预措施: metformin (Drug)
metformin and roflumilast
In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time roflumilast was initiated at a dose of 500 mg BID per os.
干预措施: metformin and roflumilast (Drug)
结局指标
主要结局
The main outcome was change in body weight.
时间窗: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.
The patient's body weight was measured in kilograms.
次要结局
- The secondary outcome was change in body mass index (BMI).(Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.)
- The secondary outcome was change in waist circumference.(Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.)
研究者
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana