Efficacy and Safety of Dapagliflozin Versus Metformin in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Fertility parameters-Follicle-stimulating hormone
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology, with insulin resistance playing a central role in its pathophysiology. Hyperinsulinemia can enhance ovarian androgen production and reduce hepatic sex hormone-binding globulin synthesis, thereby aggravating hyperandrogenism and reproductive abnormalities. Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis. Emerging evidence suggests that DPP-4 inhibition may also influence body weight, androgen excess, inflammation, and reproductive function in women with PCOS.
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
- Double (Participant, Investigator)
盲法说明
Double blinded
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
- •Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
- •Age: >18 <40 years. Infertile women (primary or secondary infertility)
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 and uncontrolled endocrine or metabolic disease.
- •Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
- •Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
研究组 & 干预措施
Metformin group
Patients will receive Metformin 1000 mg once daily orally for 12 weeks
干预措施: Metformin (Drug)
Vildagliptin group
Patients will receive vildagliptin 50 mg once daily orally for 12 weeks
干预措施: Vildagliptin (Galvus) (Drug)
结局指标
主要结局
Fertility parameters-Follicle-stimulating hormone
时间窗: 3-months
Measurement of Follicle-stimulating hormone
Fertility parameters- Luteinizing hormone
时间窗: 3 months
Measurement of Luteinizing hormone (LH)
Fertility parameters-Free androgen index
时间窗: 3-months
mesurement of Free androgen index
次要结局
未报告次要终点