[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100321314":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":65,"centralContacts":66,"locations":76,"responsibleParty":93,"collaborators":65,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":65,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":65,"maxAge":105,"enrollmentInfo":106,"targetDuration":65,"studyType":109,"phases":110,"briefSummary":113,"conditions":114,"keywords":65,"overallStatus":78,"whyStopped":65,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"West China Second University Hospital","OTHER",[8,14,19,22,27,30,34,37,41],{"label":9,"type":10,"description":11,"interventionNames":12},"MPA for EC without progesterone contraindication","ACTIVE_COMPARATOR","The enrolled patient (endometrial cancer without contraindication of oral high dose progesterone) is allocated to one of three groups, MPA only, MPA+LNG-IUS, LNG-IUS only, by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.",[13],"Drug: Progesterone",{"label":15,"type":16,"description":11,"interventionNames":17},"MPA+Mirena® for EC without contraindication","EXPERIMENTAL",[13,18],"Device: Mirena®",{"label":20,"type":16,"description":11,"interventionNames":21},"Mirena® for EC without contraindication",[18],{"label":23,"type":10,"description":24,"interventionNames":25},"GnRH agonist+Mirena® for EC with contraindication","The enrolled patient (endometrial cancer with contraindication of oral high dose progesterone) is allocated to either GnRH-a+ LNG-IUS or only LNG-IUS by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.",[18,26],"Drug: GnRH agonist",{"label":28,"type":16,"description":24,"interventionNames":29},"Mirena® for EC with contraindication",[18],{"label":31,"type":10,"description":32,"interventionNames":33},"Mirena® for EAH without progesterone contraindication","The enrolled patient (atypical endometrial hyperplasia without contraindication of oral high dose progesterone) is allocated to either MPA or LNG-IUS by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if EAH is still present after 3 cycles.",[18],{"label":35,"type":16,"description":32,"interventionNames":36},"MPA for EAH without progesterone contraindication",[13],{"label":38,"type":10,"description":39,"interventionNames":40},"Mirena® for EAH with progesterone contraindication","The enrolled patient (atypical endometrial hyperplasia with contraindication of oral high dose progesterone) is allocated to either GnRH-a+ LNG-IUS or only LNG-IUS by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if EAH is still present after 3 cycles.",[18],{"label":42,"type":16,"description":39,"interventionNames":43},"GnRH-a+Mirena® for EAH with progesterone contraindication",[18,26],[45,52,59],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Progesterone","MPA oral 250mg-500mg qd for 3 months per cycle",[35,9,15],[51],"medroxyprogesterone acetate (MPA)",{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DEVICE","Mirena®","levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle",[23,42,15,38,31,28,20],[58],"LNG-IUS",{"type":46,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"GnRH agonist","GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle",[23,42],[64],"GnRH-a",null,[67,72],{"name":68,"role":69,"phone":70,"phoneExt":65,"email":71},"ZHENG Ying, Professor","CONTACT","+8613018256012","935398163@qq.com",{"name":73,"role":69,"phone":74,"phoneExt":65,"email":75},"CHEN Si Jing, postgraduate","+86218380361314","Zhy_chd@126.com",[77],{"facility":5,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Chengdu","Sichuan","610000","China","CN",{"type":85,"coordinates":86},"Point",[87,88],104.06667,30.66667,{"lat":88,"lon":87},[91],{"name":92,"role":69,"phone":70,"phoneExt":65,"email":71},"Zheng Ying, professor",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"PRINCIPAL_INVESTIGATOR","Zheng Ying","Professor\u002FAssociate Director\u002FSupervisor of Master Student","100321314","phase-2-value-of-lng-ius-as-fertility-preserving-treatment-of-eah-and-ec-100321314",false,"NCT03463252","Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC","Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma","For Patients With Endometrial Cancer：\n\nInclusion Criteria:\n\n* ≤40 years of age:\n* Having a strong desire for fertility preservation;\n* Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;\n* Disease limited to the endometrium (stage 1A) on MRI;\n* Serum CA125\u002F199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);\n* Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.\n\nExclusion Criteria:\n\n* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;\n* Patients have lynch syndrome (LS);\n* Patients have contraindications for pregnancy;\n* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);\n* Patients refuse to participate in clinical follow-up or sign the informed consent form.\n\nFor Patients With Endometrial atypical hyperplasia：\n\nInclusion Criteria:\n\n* ≤ 40 years of age\n* Having a strong desire for fertility preservation\n* Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists\n* Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up\n\nExclusion Criteria:\n\n* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs\n* Patients have contraindications for pregnancy\n* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)\n* Patients refuse to participate in clinical follow-up or sign the informed consent form.","FEMALE","40 Years",{"count":107,"type":108},224,"ESTIMATED","INTERVENTIONAL",[111,112],"PHASE2","PHASE3","Primary end points:\n\nThis clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.\n\nSecond end points:\n\nTo analyze the appearances of side-effects.",[115,116],"Endometrial Cancer","Atypical Endometrial Hyperplasia","2021-09-03",{"date":119,"type":120},"2021-09-13","ACTUAL",{"date":122,"type":120},"2018-04-01",{"date":124,"type":108},"2030-12-30",{"name":5,"class":6},1]