[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458257":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":40,"locations":47,"responsibleParty":67,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":40,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":40,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":50,"whyStopped":40,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"GnRHa+letrozole","EXPERIMENTAL","Patients will be stratified into BMI≥28kg\u002Fm2 group and BMI\\\u003C28kg\u002Fm2 group. Patients in BMI≥28kg\u002Fm2 or BMI\\\u003C28kg\u002Fm2 group will be randomly assigned (1:1) to GnRHa+letrozole group or MA\u002FMPA group. Patients who will be assigned to GnRHa+letrozole group will receive triprorelin acetate (intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses) plus letrozole (2.5mg oral daily and no more than 24 weeks). Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.",[13,14],"Drug: Triprorelin Acetate","Drug: Letrozole 2.5mg",{"label":16,"type":17,"description":18,"interventionNames":19},"MA\u002FMPA","ACTIVE_COMPARATOR","Patients will be stratified into BMI≥28kg\u002Fm2 group and BMI\\\u003C28kg\u002Fm2 group. Patients in BMI≥28kg\u002Fm2 or BMI\\\u003C28kg\u002Fm2 group were randomly assigned (1:1) to GnRHa+letrozole group or MA\u002FMPA group.Patients assigned to MA\u002FMPA group will receive MA\u002FMPA (160 mg oral MA daily or 500 mg oral MPA daily).Then every 3 months, an hysteroscopy will be used to evaluate the endometrial condition, and the findings will be recorded.",[20,21],"Drug: Megestrol Acetate 160 MG Oral Tablet","Drug: Medroxyprogesterone Acetate 500 MG",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Megestrol Acetate 160 MG Oral Tablet","At a dosage of 160 mg\u002Fday",[16],[29],"Megestrol Acetate",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Medroxyprogesterone Acetate 500 MG","At a dosage of 500 mg\u002Fday",[16],[35],"Medroxyprogesterone Acetate",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Triprorelin Acetate","Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses",[9],null,{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Letrozole 2.5mg","At a dosage of 2.5mg\u002Fday and no more than 24 weeks",[9],[46],"Letrozole",[48],{"facility":49,"status":50,"city":51,"state":40,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Obstetrics and Gynecology Hospital, Fudan University","RECRUITING","Shanghai","200011","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":63,"role":64,"phone":65,"phoneExt":40,"email":66},"Xiaojun Chen, PhD","CONTACT","862163455055","cxjlhjj@163.com",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Xiaojun Chen","Prof.Dr.",[72],{"name":73,"class":6},"Peking Union Medical College Hospital","100458257","phase-2-gonadotropin-releasing-hormone-agonist-gnrha-plus-letrozole-in-young-women-with-early-endometrial-cancer-100458257",false,"NCT05247268","Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer","Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer","Inclusion Criteria:\n\n* Consent informed and signed\n* Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy\n* No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS)\n* Have a strong desire for remaining reproductive function or uterus\n* 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\n* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis\n* Recurrent endometrial cancer\n* Combined with severe medical disease or severely impaired liver and kidney function\n* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone\n* Those who require hysterectomy or other methods other than conservative treatment with drugs\n* Known or suspected pregnancy\n* Contraindication for Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole or pregnancy\n* Hormone treatment within 3 months before entering the trial;\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Smoker(\\>15 cigarettes a day)",true,"FEMALE","18 Years","45 Years",{"count":86,"type":87},104,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA\u002FMPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.",[93],"Endometrial Neoplasm Malignant Stage I",[95,96,97,98],"early endometrial carcinoma","fertility-preserving treatment","gonadotropin-releasing hormone analogue","aromatase inhibitors","2026-06-03",{"date":101,"type":102},"2026-06-04","ACTUAL",{"date":104,"type":102},"2022-03-11",{"date":106,"type":87},"2027-09-10",{"name":5,"class":6},1]