Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06142656
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of luteinizing hormone (LH)', 'timeFrame': 'at baseline and after 3 months', 'description': 'serum luteinizing hormone (LH)'}, {'measure': 'Concentration of Follicle-stimulating hormone', 'timeFrame': 'at baseline and after 3 months', 'description': 'Serum Follicle-stimulating hormone'}, {'measure': 'Concentration of Free androgen index', 'timeFrame': 'at baseline and after 3 months', 'description': 'serum Free androgen index'}, {'measure': 'Concentration of total testosterone', 'timeFrame': 'at baseline and after 3 months', 'description': 'serum total testosterone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Poly Cystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.\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\n* Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors\n* Eating disorders (anorexia, bulimia) or gastrointestinal disorders'}, 'identificationModule': {'nctId': 'NCT06142656', 'briefTitle': 'Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PRC-Ph-2307004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin Hydrochloride tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vildagliptin', 'interventionNames': ['Drug: Vildagliptin 50 MG']}], 'interventions': [{'name': 'Metformin Hydrochloride tablet', 'type': 'DRUG', 'description': 'Metformin Hydrochloride 850 mg oral tablet', 'armGroupLabels': ['Metformin']}, {'name': 'Vildagliptin 50 MG', 'type': 'DRUG', 'description': 'Vildagliptin 50 MG oral tablets', 'armGroupLabels': ['Vildagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12585', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed M. A, phD', 'role': 'CONTACT', 'phone': '01001749605'}, {'name': 'Hanan elhanafy', 'role': 'CONTACT', 'phone': '01281084864'}], 'facility': 'October 6 university hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'ahmed hussein, phD', 'role': 'CONTACT', 'email': 'ahmedhussein.med@o6u.edu.eg', 'phone': '01001749605'}, {'name': 'ahmed hussein', 'role': 'CONTACT', 'email': 'ahmedhussein.med@o6u.edu.eg'}], 'overallOfficials': [{'name': 'ahmed hussein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'october 6 university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'LECTURER OF CLINICAL PHARMACY', 'investigatorFullName': 'engy wahsh', 'investigatorAffiliation': 'October 6 University'}}}}