Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of luteinizing hormone (LH)
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
排除标准
- •Patients with history of diabetes mellitus (Type 1 or 2).
- •Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months
- •Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors
- •Eating disorders (anorexia, bulimia) or gastrointestinal disorders
研究组 & 干预措施
Metformin
干预措施: Metformin Hydrochloride tablet (Drug)
Vildagliptin
干预措施: Vildagliptin 50 MG (Drug)
结局指标
主要结局
Concentration of luteinizing hormone (LH)
时间窗: at baseline and after 3 months
serum luteinizing hormone (LH)
Concentration of Follicle-stimulating hormone
时间窗: at baseline and after 3 months
Serum Follicle-stimulating hormone
Concentration of Free androgen index
时间窗: at baseline and after 3 months
serum Free androgen index
Concentration of total testosterone
时间窗: at baseline and after 3 months
serum total testosterone
次要结局
未报告次要终点
研究者
engy wahsh
LECTURER OF CLINICAL PHARMACY
October 6 University