[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655262":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":31,"interventions":43,"overallOfficials":20,"centralContacts":53,"locations":20,"responsibleParty":59,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":20,"overallStatus":83,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":20},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Fertility parameters-Follicle-stimulating hormone","Measurement of Follicle-stimulating hormone","3-months",{"measure":14,"description":15,"timeFrame":16},"Fertility parameters- Luteinizing hormone","Measurement of Luteinizing hormone (LH)","3 months",{"measure":18,"description":19,"timeFrame":12},"Fertility parameters-Free androgen index","mesurement of Free androgen index",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":27,"whoMasked":28},"DOUBLE","Double blinded",[29,30],"PARTICIPANT","INVESTIGATOR",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Metformin group","ACTIVE_COMPARATOR","Patients will receive Metformin 1000 mg once daily orally for 12 weeks",[37],"Drug: Metformin",{"label":39,"type":34,"description":40,"interventionNames":41},"Vildagliptin group","Patients will receive vildagliptin 50 mg once daily orally for 12 weeks",[42],"Drug: Vildagliptin (Galvus)",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":20},"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",[33],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":20},"Vildagliptin (Galvus)","Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis.",[39],[54],{"name":55,"role":56,"phone":57,"phoneExt":20,"email":58},"Mostafa M Bahaa, PhD","CONTACT","0201025538337","mbahaa@horus.edu.eg",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Mostafa Bahaa","Lecturer","100655262","phase-2-efficacy-of-dapagliflozin-versus-metformin-in-patients-with-polycystic-ovary-syndrome-100655262",false,"NCT07811011","Efficacy of Vildagliptin Versus Metformin in Patients With Polycystic Ovary Syndrome","Efficacy and Safety of Vildagliptin Versus Metformin in Patients With 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.","FEMALE","18 Years","40 Years",{"count":74,"type":75},70,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology, with insulin resistance playing a central role in its pathophysiology. Hyperinsulinemia can enhance ovarian androgen production and reduce hepatic sex hormone-binding globulin synthesis, thereby aggravating hyperandrogenism and reproductive abnormalities. Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances endogenous incretin activity and may improve insulin sensitivity and glucose homeostasis. Emerging evidence suggests that DPP-4 inhibition may also influence body weight, androgen excess, inflammation, and reproductive function in women with PCOS.",[82],"Poly Cystic Ovary Syndrome","NOT_YET_RECRUITING","2026-09-15",{"date":86,"type":87},"2026-09-21","ACTUAL",{"date":89,"type":75},"2026-09-20",{"date":91,"type":75},"2027-03-30",{"name":5,"class":6}]