[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454688":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":51,"locations":62,"responsibleParty":83,"collaborators":56,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":56,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":56,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":107,"whyStopped":56,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin arm (control group)","ACTIVE_COMPARATOR","Patients will receive Metformin (1500 mg orally\u002Fday) for 12 weeks .",[13],"Drug: Metformin 1500 mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Empagliflozin arm","Patients will receive Empagliflozin (25 mg orally\u002Fday) for 12 weeks.",[18],"Drug: Empagliflozin 25 mg",{"label":20,"type":10,"description":21,"interventionNames":22},"Linagliptin arm","Patients will receive Linagliptin (10 mg orally\u002Fday) for 12 weeks",[23],"Drug: Linagliptin 10 mg",[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Empagliflozin 25 mg","This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)",[15],[31],"Empagliflozin",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"Linagliptin 10 mg",[20],[36],"Linagliptin",{"type":26,"name":38,"description":28,"armGroupLabels":39,"otherNames":40},"Metformin 1500 mg",[9],[41],"Metformin",[43,47],{"name":44,"affiliation":45,"role":46},"Hanan N Abdel Hafez, PhD","Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University","STUDY_CHAIR",{"name":48,"affiliation":49,"role":50},"Ahmed I ElMallah, PhD","Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University","PRINCIPAL_INVESTIGATOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Haidy M Sami, Master","CONTACT","+201015299642",null,"gs-haidy.sami@alexu.edu.eg",{"name":59,"role":54,"phone":60,"phoneExt":56,"email":61},"Noha A Hamdy, PhD","+201005182151","noha.alaaeldine@alexu.edu.eg",[63],{"facility":5,"status":64,"city":65,"state":56,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Alexandria","21521","Egypt","EG",{"type":70,"coordinates":71},"Point",[72,73],29.91582,31.20176,{"lat":73,"lon":72},[76,79,80,81],{"name":48,"role":54,"phone":77,"phoneExt":56,"email":78},"+201001708794","ahmed.elmallah@alexu.edu.eg]",{"name":44,"role":50,"phone":56,"phoneExt":56,"email":56},{"name":59,"role":50,"phone":56,"phoneExt":56,"email":56},{"name":82,"role":50,"phone":56,"phoneExt":56,"email":56},"Haidi M Sami, Master",{"type":50,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Ahmed Ibrahim ElMallah","Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University","100454688","phase-4-efficacy-of-empagliflozin-or-linagliptin-as-an-alternative-to-metformin-for-treatment-of-polycystic-ovary-syndrome-100454688",false,"NCT05200793","Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome","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","Inclusion Criteria:\n\n1. Women diagnosed with PCOS according to National Institute of Health criteria.\n2. Age: \\>18 \\\u003C40 years.\n3. Infertile women (primary or secondary infertility).\n\nExclusion Criteria:\n\n1. Patients with history of diabetes mellitus (Type 1 or 2).\n2. Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.\n3. Significantly elevated triglyceride levels (fasting triglyceride \\> 400 mg\u002FdL)\n4. Untreated or poorly controlled hypertension (sitting blood pressure \\> 160\u002F95 mm Hg).\n5. 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.\n6. 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.\n7. Presence of hypersensitivity to Empagliflozin or other Sodium\u002Fglucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).\n8. Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…).\n9. Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.\n10. Eating disorders (anorexia, bulimia) or gastrointestinal disorders.\n11. Having a history of bariatric surgery.","FEMALE","18 Years","40 Years",{"count":97,"type":98},75,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","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).",[104],"Polycystic Ovary Syndrome (PCOS)",[106,31,36,41],"PCOS","UNKNOWN","2022-01-14",{"date":110,"type":111},"2022-01-21","ACTUAL",{"date":113,"type":111},"2021-12-07",{"date":115,"type":98},"2022-09-01",{"name":5,"class":6},1]