[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655259":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":19,"armGroups":30,"interventions":42,"overallOfficials":19,"centralContacts":52,"locations":19,"responsibleParty":58,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":19,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":19,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":19,"overallStatus":81,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":19},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Fertility parameters- Luteinizing hormone","Measurement of Luteinizing hormone","3-months",{"measure":14,"description":15,"timeFrame":12},"Fertility parameters- Follicle stimulating hormone","Measurment of Luteinizing hormone",{"measure":17,"description":18,"timeFrame":12},"Fertility parameters-Total testosterone","Measurement of Total testosterone",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"DOUBLE","Double blinded",[28,29],"PARTICIPANT","INVESTIGATOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Metformin arm","ACTIVE_COMPARATOR","Patients will receive Metformin 1000 mg once daily orally for 12 weeks",[36],"Drug: Metformin",{"label":38,"type":33,"description":39,"interventionNames":40},"Dapagliflozin arm","Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks",[41],"Drug: Dapagliflozin (10mg Tab)",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":19},"DRUG","Metformin","Metformin is a widely used insulin-sensitizing agent and one of the most established pharmacological treatments for the metabolic abnormalities associated with polycystic ovary syndrome (PCOS).",[32],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":19},"Dapagliflozin (10mg Tab)","Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that promotes urinary glucose and sodium excretion by reducing renal glucose reabsorption. Beyond its established role in type 2 diabetes, dapagliflozin has attracted interest as a potential therapeutic option for polycystic ovary syndrome",[38],[53],{"name":54,"role":55,"phone":56,"phoneExt":19,"email":57},"Mostafa M Bahaa, PhD","CONTACT","01025538337","mbahaa@horus.edu.eg",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Mostafa Bahaa","Lecturer","100655259","phase-2-efficacy-of-dapagliflozin-versus-metformin-in-polycystic-ovary-syndrome-100655259",false,"NCT07810998","Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome","Inclusion Criteria:\n\nWomen diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.\n\nAge: \\>18 \\\u003C40 years. Infertile women (primary or secondary infertility)\n\nExclusion Criteria:\n\nPatients 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.\n\nUse 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\nPatients 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\nPresence of hypersensitivity to dapagliflozin or other Sodium\u002Fglucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).\n\nUse of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors Eating disorders (anorexia, bulimia) or gastrointestinal disorders. Having a history of bariatric surgery.","FEMALE","18 Years","40 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE2","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).",[80],"Poly Cystic Ovary Syndrome","NOT_YET_RECRUITING","2026-09-02",{"date":84,"type":85},"2026-09-09","ACTUAL",{"date":87,"type":73},"2026-09-10",{"date":89,"type":73},"2027-05-10",{"name":5,"class":6}]