[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463576":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":84,"collaborators":59,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":59,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":59,"studyType":101,"phases":102,"briefSummary":105,"conditions":106,"keywords":59,"overallStatus":67,"whyStopped":59,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"overweight MA+ILI","EXPERIMENTAL","enrolled overweight (24kg\u002Fm2≤BMI\\\u003C28kg\u002Fm2) patients will receive megestrol acetate 160mg po qd plus weight management",[13,14],"Behavioral: Intensive Lifestyle Intervention (ILI)","Drug: Megestrol Acetate 160 MG Oral Tablet",{"label":16,"type":10,"description":17,"interventionNames":18},"overweight LNG-IUS+ILI","enrolled overweight (24kg\u002Fm2≤BMI\\\u003C28kg\u002Fm2) patients will be treated with LNG-IUS plus weight management",[13,19],"Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg",{"label":21,"type":10,"description":22,"interventionNames":23},"obese MA+ILI","enrolled obese (BMI≥28kg\u002Fm2) patients will receive megestrol acetate 160mg po qd plus weight management",[13,14],{"label":25,"type":10,"description":26,"interventionNames":27},"obese LNG-IUS+ILI","enrolled obese (BMI≥28kg\u002Fm2) patients will be treated with LNG-IUS plus weight management",[13,19],[29,36,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Intensive Lifestyle Intervention (ILI)","dietary guidance, exercise guidance, lifestyle intervention",[25,21,16,9],[35],"Weight Management",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Megestrol Acetate 160 MG Oral Tablet","enrolled participants will take Megestrol Acetate 160mg daily",[21,9],[42],"yilizhi",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg","enrolled patients will be treated with LNG-IUS.",[25,16],[48],"manyuele",[50],{"name":51,"affiliation":52,"role":53},"XIAOJUN CHEN, PhD","Obstetrics & Gynecology Hospital of Fudan University","PRINCIPAL_INVESTIGATOR",[55,61],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"WEIWEI SHAN, PhD","CONTACT","8613817813106",null,"danweiwei7468@fckyy.org.cn",{"name":51,"role":57,"phone":62,"phoneExt":59,"email":63},"8613601680784","cxjlhjj@163.com",[65],{"facility":66,"status":67,"city":68,"state":59,"zip":59,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Obstetrics and Gynecology Hospital of Fudan University","RECRUITING","Shanghai","China","CN",{"type":72,"coordinates":73},"Point",[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78,81],{"name":56,"role":57,"phone":79,"phoneExt":59,"email":80},"13817813106","fdsww1024@sina.cn",{"name":82,"role":57,"phone":83,"phoneExt":59,"email":59},"DANDAN JU, MD","021-33189900-8408",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"SPONSOR_INVESTIGATOR","Xiaojun Chen","Principal Investigator","100463576","phase-2-weight-management-plus-lng-iusmegestrol-acetate-in-endometrial-atypical-hyperplasia-100463576",false,"NCT05316493","Weight Management Plus LNG-IUS\u002FMegestrol Acetate in Endometrial Atypical Hyperplasia","Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study","Inclusion Criteria:\n\n1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg\u002Fm2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.\n\n5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.\n\n6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.\n\nExclusion Criteria:\n\n1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \\\u003C 30 mL\u002Fmin)\n2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.\n3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).\n4. Those who require hysterectomy or other methods other than conservative treatment.\n5. Known or suspected pregnancy.\n6. Those who has contraindications to use progestin.\n7. Deep vein thrombosis, stroke, myocardial infarction.\n8. Severe joint lesions that prevent walking or movement.\n9. untreated or recurrent pelvic inflammatory disease (PID)\n10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);\n11. Cervical dysplasia\n12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus\n13. allergic to the LNG-IUS components\n14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.\n\nNotes: the last 6 criteria are only applied for patients with LNG-IUS.","FEMALE","18 Years","45 Years",{"count":99,"type":100},172,"ESTIMATED","INTERVENTIONAL",[103,104],"PHASE2","PHASE3","To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.",[107,108,109],"Atypical Endometrial Hyperplasia","Fertility Issues","Overweight and Obesity","2026-06-03",{"date":112,"type":113},"2026-06-04","ACTUAL",{"date":115,"type":113},"2022-06-13",{"date":117,"type":100},"2027-02-28",{"name":86,"class":6},1]