Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT05200793
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2021-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-12-12', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertility parameters', 'timeFrame': '3-6 months', 'description': '\\[luteinizing hormone (LH)'}, {'measure': 'Follicle-stimulating hormone', 'timeFrame': '3-6 months', 'description': 'FSH'}, {'measure': 'Free androgen index', 'timeFrame': '3-6 months', 'description': 'total testosterone \\& sex hormone binding globulin (SHBG)'}, {'measure': 'Transvaginal ultrasonography', 'timeFrame': '3-6 months', 'description': 'disappearance of PCOS'}, {'measure': 'Menstrual diaries', 'timeFrame': '3-6 months', 'description': 'regulate menses cycles'}], 'secondaryOutcomes': [{'measure': 'Metabolic parameters', 'timeFrame': '3-6 months', 'description': 'Fasting blood glucose level'}, {'measure': 'Lipid profile (metabolic parameters)', 'timeFrame': '3-6 months', 'description': 'Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II'}, {'measure': 'Inflammatory indices', 'timeFrame': '3-6 months', 'description': 'Interleukin 6 or Toll Like receptor 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS', 'Empagliflozin', 'Linagliptin', 'Metformin'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Patients with polycystic ovary syndrome will be randomized to three arms:\n\n* Metformin (standard care)\n* Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study is for the treatment of polycystic ovary syndrome (PCOS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women diagnosed with PCOS according to National Institute of Health criteria.\n2. Age: \\>18 \\<40 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/dL)\n4. Untreated or poorly controlled hypertension (sitting blood pressure \\> 160/95 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/glucose 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.'}, 'identificationModule': {'nctId': 'NCT05200793', 'briefTitle': 'Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '0201566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin arm (control group)', 'description': 'Patients will receive Metformin (1500 mg orally/day) for 12 weeks .', 'interventionNames': ['Drug: Metformin 1500 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin arm', 'description': 'Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.', 'interventionNames': ['Drug: Empagliflozin 25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Linagliptin arm', 'description': 'Patients will receive Linagliptin (10 mg orally/day) for 12 weeks', 'interventionNames': ['Drug: Linagliptin 10 mg']}], 'interventions': [{'name': 'Empagliflozin 25 mg', 'type': 'DRUG', 'otherNames': ['Empagliflozin'], 'description': '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)', 'armGroupLabels': ['Empagliflozin arm']}, {'name': 'Linagliptin 10 mg', 'type': 'DRUG', 'otherNames': ['Linagliptin'], 'description': '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)', 'armGroupLabels': ['Linagliptin arm']}, {'name': 'Metformin 1500 mg', 'type': 'DRUG', 'otherNames': ['Metformin'], 'description': '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)', 'armGroupLabels': ['Metformin arm (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21521', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed I ElMallah, PhD', 'role': 'CONTACT', 'email': 'ahmed.elmallah@alexu.edu.eg]', 'phone': '+201001708794'}, {'name': 'Hanan N Abdel Hafez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Noha A Hamdy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Haidi M Sami, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Haidy M Sami, Master', 'role': 'CONTACT', 'email': 'gs-haidy.sami@alexu.edu.eg', 'phone': '+201015299642'}, {'name': 'Noha A Hamdy, PhD', 'role': 'CONTACT', 'email': 'noha.alaaeldine@alexu.edu.eg', 'phone': '+201005182151'}], 'overallOfficials': [{'name': 'Hanan N Abdel Hafez, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University'}, {'name': 'Ahmed I ElMallah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University', 'investigatorFullName': 'Ahmed Ibrahim ElMallah', 'investigatorAffiliation': 'Alexandria University'}}}}