[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580348":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":43,"locations":52,"responsibleParty":65,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":31,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Cairo University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group-MN","EXPERIMENTAL","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)",[13,14],"Drug: N-acetyl cysteine","Drug: Metfomin",{"label":16,"type":10,"description":17,"interventionNames":18},"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)",[14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","N-acetyl cysteine","N-Acetyl Cysteine (NAC) has antioxidant properties and is essential for the body's production of glutathione, and both glutathione and NAC are potent antioxidants.",[9],[26],"NAC",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Metfomin","metformin is commonly used for managing polycystic ovary syndrome (PCOS) due to its benefits in addressing several underlying features of the condition. While it is not officially approved by regulatory agencies like the FDA for PCOS, it is widely recognized and recommended in clinical practice guidelines as an off-label treatment for PCOS, particularly in women with insulin resistance and metabolic dysfunction.",[16,9],null,[33,37,40],{"name":34,"affiliation":35,"role":36},"Samar F Farid, PhD","Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University","STUDY_DIRECTOR",{"name":38,"affiliation":39,"role":36},"Eglal A Mostafa Bassiouny, PhD","Lecturer of Clinical Pharmacy Faculty of Pharmacy, Cairo University",{"name":41,"affiliation":42,"role":36},"Amr Z Abdelhamid, PhD","Obstetrics and Gynaecology Lecturer Kasr Al-Ainy School of Medicine, Cairo University",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":31,"email":48},"Marwa R Talat, BPharm","CONTACT","+201069342847","marwa.rafat@pharma.cu.edu.eg",{"name":38,"role":46,"phone":50,"phoneExt":31,"email":51},"+201061500242","eglal.mostafa@pharma.cu.edu.eg",[53],{"facility":54,"status":55,"city":56,"state":31,"zip":31,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":31},"Kasr El-Ainy hospital","RECRUITING","Cairo","Egypt","EG",{"type":60,"coordinates":61},"Point",[62,63],31.24967,30.06263,{"lat":63,"lon":62},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Marwa Rafat Talat","Demonstrator and Teaching assistant","100580348","phase-3-the-combined-effect-of-n-acetyl-cysteine-and-metformin-in-polycystic-ovary-syndrome-patients-100580348",false,"NCT06836128","The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients","PCOS","Inclusion Criteria:\n\n1. Female aged 20 to 45 years old.\n2. Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.\n3. Ability to give informed consent.\n\nExclusion Criteria:\n\n1. Hypersensitivity to either metformin or NAC.\n2. Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.\n3. Hyperprolactinemia, defined as a prolactin level above laboratory reference range.\n4. Diabetes mellitus.\n5. Thyroid dysfunction, subjects with elevated or low TSH level.\n6. Renal impairment where creatinine clearance (CrCl) less than 30 ml\u002Fmin.\n7. 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).\n8. Active alcohol abuse.\n9. History of lactic acidosis during metformin therapy.\n10. Active peptic ulcer.\n11. Congenital adrenal hyperplasia.\n12. Cushing's syndrome.\n13. Androgen secreting neoplasia.\n14. 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.\n15. Decompensated heart failure.","FEMALE","20 Years","45 Years",{"count":80,"type":81},102,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.",[87],"Polycystic Ovary Syndrome",[74,26,89],"metformin","2025-07-04",{"date":92,"type":93},"2025-07-09","ACTUAL",{"date":95,"type":93},"2025-03-01",{"date":97,"type":81},"2026-05-01",{"name":5,"class":6},1]