[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463610":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":41,"centralContacts":52,"locations":62,"responsibleParty":98,"collaborators":41,"id":101,"slug":41,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":41,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":41,"studyType":113,"phases":114,"briefSummary":117,"conditions":118,"keywords":41,"overallStatus":65,"whyStopped":41,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-obese EEC group (G)","EXPERIMENTAL","20 non-obese EEC patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.",[13,14],"Drug: GnRHa","Drug: Letrozole 2.5mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Non-obese EEC group (D)","20 non-obese EEC patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.",[19,20],"Drug: Diane-35","Drug: MET",{"label":22,"type":10,"description":23,"interventionNames":24},"Non-obese EAH group (G)","20 non-obese EAH patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.",[13,14],{"label":26,"type":10,"description":27,"interventionNames":28},"Non-obese EAH group (D)","20 non-obese EAH patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.",[19,20],[30,37,42,48],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","GnRHa","Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.",[22,9],[36],"Triprorelin acetate",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Letrozole 2.5mg","2.5mg po qd and no more than 24 weeks",[22,9],null,{"type":31,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Diane-35","Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.",[26,16],[47],"ethinylestradiol cyproterone",{"type":31,"name":49,"description":50,"armGroupLabels":51,"otherNames":41},"MET","500mg po tid",[26,16],[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Xiaojun Chen, PhD","CONTACT","8602133189900","6429","cxjlhjj@163.com",{"name":60,"role":55,"phone":56,"phoneExt":57,"email":61},"Bingyi Yang","xiaomihaoku@163.com",[63,88],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Obstetrics and Gynecology Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200011","China",{"type":71,"coordinates":72},"Point",[73,74],121.45806,31.22222,{"lat":74,"lon":73},[77,79,81,84,86],{"name":54,"role":55,"phone":78,"phoneExt":57,"email":58},"862133189900",{"name":80,"role":55,"phone":78,"phoneExt":57,"email":61},"Bingyi Yang, MD",{"name":82,"role":83,"phone":41,"phoneExt":41,"email":41},"Xiaojun Chen","PRINCIPAL_INVESTIGATOR",{"name":60,"role":85,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"name":87,"role":85,"phone":41,"phoneExt":41,"email":41},"Pengfei Wu",{"facility":89,"status":65,"city":66,"state":67,"zip":41,"country":69,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Tenth People's Hospital of Tongji University",{"type":71,"coordinates":91},[73,74],{"lat":74,"lon":73},[94],{"name":95,"role":55,"phone":96,"phoneExt":41,"email":97},"Weina Wang","8602166300588","wangweinals@163.com",{"type":99,"investigatorFullName":82,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Professor","100463610",false,"NCT05316935","GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients","Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment","Inclusion Criteria:\n\n* Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion\n* BMI\\\u003C30kg\u002Fm2\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Using progestin, any of the following therapy, as first-line treatment:\n\n  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not\n  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not\n  3. LNG-IUS inserted\n* Progestin-insensitive:\n\n  1. remained with stable disease after 7 months of progestin use\n  2. did not achieve CR after 10 months of progestin use\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Combined with severe medical disease or severely impaired liver and kidney function\n* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis\n* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system\n* Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET\n* Strong request for uterine removal or other conservative treatment\n* Known or suspected pregnancy\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Smoker(\\>15 cigarettes a day)","FEMALE","18 Years","45 Years",{"count":111,"type":112},80,"ESTIMATED","INTERVENTIONAL",[115,116],"PHASE2","PHASE3","To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.",[119,120,121],"Endometrial Neoplasms","Atypical Endometrial Hyperplasia","Progesterone Resistance","2025-08-06",{"date":124,"type":125},"2025-08-11","ACTUAL",{"date":127,"type":125},"2022-07-13",{"date":129,"type":112},"2027-03-30",{"name":82,"class":6},2]