A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Follicle-stimulating hormone
研究概览
简要总结
The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).
详细描述
Patients with polycystic ovary syndrome will be randomized to three arms:
- Metformin (standard care)
- Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested
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
- •Women diagnosed with PCOS according to 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.
- •Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
- •Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).
- •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.
- •Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
- •Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin...).
- •Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
- •Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
- •Having a history of bariatric surgery.
研究组 & 干预措施
Metformin arm (control group)
Patients will receive Metformin (1500 mg orally/day) for 12 weeks .
干预措施: Metformin 1500 mg (Drug)
Empagliflozin arm
Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.
干预措施: Empagliflozin 25 mg (Drug)
Linagliptin arm
Patients will receive Linagliptin (10 mg orally/day) for 12 weeks
干预措施: Linagliptin 10 mg (Drug)
结局指标
主要结局
Follicle-stimulating hormone
时间窗: 3-6 months
FSH
Free androgen index
时间窗: 3-6 months
total testosterone \& sex hormone binding globulin (SHBG)
Menstrual diaries
时间窗: 3-6 months
regulate menses cycles
Fertility parameters
时间窗: 3-6 months
\[luteinizing hormone (LH)
Transvaginal ultrasonography
时间窗: 3-6 months
disappearance of PCOS
次要结局
- Metabolic parameters(3-6 months)
- Lipid profile (metabolic parameters)(3-6 months)
- Inflammatory indices(3-6 months)
研究者
Ahmed Ibrahim ElMallah
Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University
Alexandria University