The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Primary outcome will be change in LH/FSH levels.
研究概览
简要总结
The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.
详细描述
Polycystic ovarian syndrome (PCOS) is one of the prevalent endocrine illnesses that affects women in industrialized and developing nations, with a prevalence that ranges from 8% to 13%. The most widely accepted criteria for diagnosing polycystic ovary syndrome (PCOS) are the Rotterdam criteria established in 20032. According to these criteria, a diagnosis is made if a patient meets at least two of the following three criteria:
The Rotterdam criteria
Polycystic ovarian syndrome is diagnosed when 2 out of 3 criteria are met:
- Oligo-or/and anovulation
- Clinical hyperandrogenism (acne, hirsutism, alopecia) or biochemical hyperandrogenism.
- Polycystic ovarian morphology on transvaginal ultrasonography or high antimullerian hormone.
And exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 20 to 45 years old.
- •Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.
- •Ability to give informed consent.
排除标准
- •Hypersensitivity to either metformin or NAC.
- •Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.
- •Hyperprolactinemia, defined as a prolactin level above laboratory reference range.
- •Diabetes mellitus.
- •Thyroid dysfunction, subjects with elevated or low TSH level.
- •Renal impairment where creatinine clearance (CrCl) less than 30 ml/min.
- •Severe hepatic impairment, defined as significant biochemical abnormalities, including hypoalbuminemia and abnormal serum concentration (2-3 times the upper limit of normal), of at least two of the following liver function markers: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT).
- •Active alcohol abuse.
- •History of lactic acidosis during metformin therapy.
- •Active peptic ulcer.
- •Congenital adrenal hyperplasia.
- •Cushing's syndrome.
- •Androgen secreting neoplasia.
- •Patients who were using spironolactone, other anti-androgens, or any form of hormone therapy for the treatment of hirsutism at least 3 months before enrollment in the study.
- •Decompensated heart failure.
研究组 & 干预措施
Group-MN
Group-MN, constituting 51 cases, will receive N-acetyl cysteine and metformin (600 mg three times daily of acetyl cysteine and 500 mg once daily for one week, then 500 mg twice daily for one week, and 500 mg three times daily thereafter of metformin)
干预措施: N-acetyl cysteine (Drug)
Group-MN
Group-MN, constituting 51 cases, will receive N-acetyl cysteine and metformin (600 mg three times daily of acetyl cysteine and 500 mg once daily for one week, then 500 mg twice daily for one week, and 500 mg three times daily thereafter of metformin)
干预措施: Metfomin (Drug)
Group-M
Group-M, constituting 51 cases, will receive treatment with metformin (starting with 500 mg once daily for one week, then 500 mg twice daily for one week, and 500 mg three times daily thereafter)
干预措施: Metfomin (Drug)
结局指标
主要结局
Primary outcome will be change in LH/FSH levels.
时间窗: 3 months
change in LH/FSH ratio
次要结局
- improvement in hormonal levels in patients with PCOS(3 months)
- improvement in clinical features in patients with PCOS(3 months)
- improvement in biochemical parameters in patients with PCOS(3 months)
- improvement in metabolic parameters in patients with PCOS(3 months)
研究者
Marwa Rafat Talat
Demonstrator and Teaching assistant
Cairo University