Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2026-02-07 @ 11:33 AM
Study NCT ID:
NCT02872818
Status:
COMPLETED
Last Update Posted:
2016-08-23
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004714', 'term': 'Endometrial Hyperplasia'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine 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': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivin Gene Expression Levels in Rat Uterine Tissue', 'timeFrame': '4 months'}, {'measure': 'Bcl-2 Gene Expression Levels in Rat Uterine Tissue', 'timeFrame': '4 months'}, {'measure': 'Bax Gene Expression Levels in Rat Uterine Tissue', 'timeFrame': '4 months'}, {'measure': 'c-Myc Gene Expression Levels in Rat Uterine Tissue', 'timeFrame': '4 months'}, {'measure': 'Caspase-9 Expression Levels in Rat Uterine Tissue', 'timeFrame': '4 months'}]}, 'conditionsModule': {'keywords': ['Apoptotic signal pathway', 'Survivin', 'Bcl-2', 'Bax', 'c-Myc', 'Caspase-9', 'endometrial hyperplasia', 'endometrium cancer'], 'conditions': ['Apoptotic Signal Pathways in Endometrial Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine apoptotic signaling pathways such as Survivin, Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial hyperplasia after metformin and medroxyprogesterone acetate administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nForty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g\n\nExclusion criteria.\n\nWe have no exclusion criteria because we examine drugs effects in the experimental rats'}, 'identificationModule': {'nctId': 'NCT02872818', 'briefTitle': 'Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'officialTitle': 'The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia', 'orgStudyIdInfo': {'id': '14/128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia', 'interventionNames': ['Drug: 17β estradiol hemihydrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin group', 'description': 'Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days', 'interventionNames': ['Drug: 17β estradiol hemihydrate', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medroxyprogesterone acetate group', 'description': 'Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days', 'interventionNames': ['Drug: 17β estradiol hemihydrate', 'Drug: medroxyprogesterone acetate']}], 'interventions': [{'name': '17β estradiol hemihydrate', 'type': 'DRUG', 'description': '4mg/kg/day for 20 days', 'armGroupLabels': ['Control group', 'Medroxyprogesterone acetate group', 'Metformin group']}, {'name': 'Metformin', 'type': 'DRUG', 'description': '50 mg/kg/day last 10 days', 'armGroupLabels': ['Metformin group']}, {'name': 'medroxyprogesterone acetate', 'type': 'DRUG', 'description': '1mg/kg/day last 10 days', 'armGroupLabels': ['Medroxyprogesterone acetate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Training and Research Hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Erdem SAHİN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kayseri Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erdem Sahin', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}