[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463610":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":41,"centralContacts":52,"locations":62,"responsibleParty":99,"collaborators":41,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":41,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":41,"studyType":115,"phases":116,"briefSummary":119,"conditions":120,"keywords":41,"overallStatus":65,"whyStopped":41,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"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",[63,89],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Obstetrics and Gynecology Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200011","China","CN",{"type":72,"coordinates":73},"Point",[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78,80,82,85,87],{"name":54,"role":55,"phone":79,"phoneExt":57,"email":58},"862133189900",{"name":81,"role":55,"phone":79,"phoneExt":57,"email":61},"Bingyi Yang, MD",{"name":83,"role":84,"phone":41,"phoneExt":41,"email":41},"Xiaojun Chen","PRINCIPAL_INVESTIGATOR",{"name":60,"role":86,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"name":88,"role":86,"phone":41,"phoneExt":41,"email":41},"Pengfei Wu",{"facility":90,"status":65,"city":66,"state":67,"zip":41,"country":69,"countryCode":70,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Tenth People's Hospital of Tongji University",{"type":72,"coordinates":92},[74,75],{"lat":75,"lon":74},[95],{"name":96,"role":55,"phone":97,"phoneExt":41,"email":98},"Weina Wang","8602166300588","wangweinals@163.com",{"type":100,"investigatorFullName":83,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Professor","100463610","phase-2-gnrha--letrozole-in-non-obese-progestin-insensitive-endometrial-cancer-and-atypical-hyperplasia-patients-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":113,"type":114},80,"ESTIMATED","INTERVENTIONAL",[117,118],"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.",[121,122,123],"Endometrial Neoplasms","Atypical Endometrial Hyperplasia","Progesterone Resistance","2025-08-06",{"date":126,"type":127},"2025-08-11","ACTUAL",{"date":129,"type":127},"2022-07-13",{"date":131,"type":114},"2027-03-30",{"name":83,"class":6},2]