Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04385667
Status:
COMPLETED
Last Update Posted:
2023-01-03
First Post:
2020-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004714', 'term': 'Endometrial Hyperplasia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-30', 'studyFirstSubmitDate': '2020-05-09', 'studyFirstSubmitQcDate': '2020-05-09', 'lastUpdatePostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate to accomplish complete regression of atypical endometrial hyperplasia', 'timeFrame': '15 month', 'description': 'The success rate to accomplish complete regression of atypical endometrial hyperplasia'}], 'secondaryOutcomes': [{'measure': 'a- Duration needed to accomplish the complete recovery', 'timeFrame': '15 months', 'description': 'time till regression'}, {'measure': 'b- The partial regression and failure rates.', 'timeFrame': '8 months', 'description': 'incidence of partial regression and therapy failure'}, {'measure': 'c- Differential response rates between premenopausal and postmenopausal cases.', 'timeFrame': '15 months', 'description': 'response rate in both premenopause and postmenopause women'}, {'measure': 'd- The risk of thromboembolic complications', 'timeFrame': '15 months', 'description': 'incidence of thromboembolism with therapy'}, {'measure': 'f- Metabolic complications rates', 'timeFrame': '15 months', 'description': 'occurence of diabetes or hypertension ...ets'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atypical endometrial hyperplasia', 'levonorgestrel intrauterine system', 'Megestrol acetate', 'partial regression'], 'conditions': ['Atypical Endometrial Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '22863972', 'type': 'BACKGROUND', 'citation': 'Armstrong AJ, Hurd WW, Elguero S, Barker NM, Zanotti KM. Diagnosis and management of endometrial hyperplasia. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):562-71. doi: 10.1016/j.jmig.2012.05.009. Epub 2012 Aug 3.'}, {'pmid': '20613899', 'type': 'BACKGROUND', 'citation': 'Salman MC, Usubutun A, Boynukalin K, Yuce K. Comparison of WHO and endometrial intraepithelial neoplasia classifications in predicting the presence of coexistent malignancy in endometrial hyperplasia. J Gynecol Oncol. 2010 Jun;21(2):97-101. doi: 10.3802/jgo.2010.21.2.97. Epub 2010 Jun 30.'}, {'pmid': '26428941', 'type': 'BACKGROUND', 'citation': 'Zhou R, Yang Y, Lu Q, Wang J, Miao Y, Wang S, Wang Z, Zhao C, Wei L. Prognostic factors of oncological and reproductive outcomes in fertility-sparing treatment of complex atypical hyperplasia and low-grade endometrial cancer using oral progestin in Chinese patients. Gynecol Oncol. 2015 Dec;139(3):424-8. doi: 10.1016/j.ygyno.2015.09.078. Epub 2015 Sep 30.'}, {'pmid': '20934679', 'type': 'BACKGROUND', 'citation': 'Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037.'}, {'pmid': '38425141', 'type': 'DERIVED', 'citation': 'Alnemr AA, Harb OA, Atia H. The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e62. doi: 10.3802/jgo.2024.35.e62. Epub 2024 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial is aimed to compare the efficacy between Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.', 'detailedDescription': 'Up to 25% of cases with endometrial cancer and atypical hyperplasia occur in premenopausal women. The progressively increasing trend of delay in first conception increases such patients who wish to have children.3 The recommended treatment for EH without atypia is primarily hormonal, whereas the preferred treatment for EH with atypia is hysterectomy given the significant risk for both concurrent and subsequent development of endometrial carcinoma. A dilemma results when EH with atypia is diagnosed in women who wish to retain fertility or declining doing hysterectomy due to concomitant medical morbidities. In these women, a trial of hormone therapy can be considered.4,5 In recent years, progestin therapy has been successfully used to treat selected women with endometrial cancer and atypical hyperplasia who desire to preserve fertility or having severe medical co-morbidities precluding (immediate) surgery. The most common progestin regimens include Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD).5-7'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy\n\nExclusion Criteria:\n\n* Cases with evidence of associated endometrial cancer.\n* Cases with simple hyperplasia without atypia.\n* Patients failed to collect at least 2 endometrial samples during treatment course.'}, 'identificationModule': {'nctId': 'NCT04385667', 'briefTitle': 'LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'LVN-IUS vs Megace for AEH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'levonorgestrel intrauterine system (LNG-IUD)', 'description': 'levonorgestrel intrauterine system (LNG-IUD) applied.\n\n* Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.\n* Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.\n* Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.', 'interventionNames': ['Device: levonorgestrel intrauterine system (LNG-IUD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Megestrol acetate (MA)', 'description': 'Megesterol arm will receive 160 mg daily\n\n* Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.\n* Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.\n* Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.', 'interventionNames': ['Drug: Oral Megesterol 160 mg daily']}], 'interventions': [{'name': 'levonorgestrel intrauterine system (LNG-IUD)', 'type': 'DEVICE', 'otherNames': ['• Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.'], 'description': 'progestin delivery for regression of atypical endometrial hyperplasia', 'armGroupLabels': ['levonorgestrel intrauterine system (LNG-IUD)']}, {'name': 'Oral Megesterol 160 mg daily', 'type': 'DRUG', 'otherNames': ['• Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.'], 'description': 'progestin delivery for regression of atypical endometrial hyperplasia', 'armGroupLabels': ['Megestrol acetate (MA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Amr Alnemr, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine- Zagazig university'}, {'name': 'Hytham Atia, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine- Zagazig university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Obstetrics & Gynecology', 'investigatorFullName': 'Hytham Atia', 'investigatorAffiliation': 'Zagazig University'}}}}