[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560379":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":52,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Future University in Egypt","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapagliflozin","ACTIVE_COMPARATOR","Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)",[13],"Drug: Dapagliflozin",{"label":15,"type":10,"description":16,"interventionNames":17},"Metformin","Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)",[18],"Drug: Metformin",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","oral Dapagliflozin",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"oral metformin",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Nouran Omar","CONTACT","01006526452","+2","nomar@fue.edu.eg",[36],{"facility":37,"status":38,"city":39,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"October 6 University Hospital","RECRUITING","Giza","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],31.20861,30.00944,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":51,"phoneExt":33,"email":24},"Ahmed Hussein","01001749605",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Nouran Omar El Said","Lecturer in Pharmacy Practice & Clinical Pharmacy",[57],{"name":58,"class":6},"October 6 University","100560379","phase-3-efficacy-of-dapagliflozin-versus-metformin-in-polycystic-ovary-syndrome-100560379",false,"NCT06576375","Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome","Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome: A Prospective Comparative Randomized Blinded Trial.","Inclusion Criteria:\n\n* Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.\n* Age: \\>18 \\\u003C40 years.\n* Infertile women (primary or secondary infertility)\n\nExclusion Criteria:\n\n* Patients with history of diabetes mellitus (Type 1 or 2).\n* Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.\n* 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.\n* 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.\n* Presence of hypersensitivity to dapagliflozin or other Sodium\u002Fglucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).\n* Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors\n* Eating disorders (anorexia, bulimia) or gastrointestinal disorders.\n* Having a history of bariatric surgery.","FEMALE","18 Years","40 Years",{"count":70,"type":71},70,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight\u002Fobese individuals.\n\nConflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).",[77],"Polycystic Ovary Syndrome","2024-10-18",{"date":80,"type":81},"2024-10-22","ACTUAL",{"date":83,"type":81},"2024-09-02",{"date":85,"type":71},"2025-01",{"name":5,"class":6},1]