[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-hyperplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-hyperplasia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100521714","phase-2-weight-loss-drug-for-fertility-sparing-treatment-of-atypical-hyperplasia-and-low-grade-cancer-of-the-endometrium-100521714",false,"NCT06073184","Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium","Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)","WE-FiERCE","Inclusion Criteria:\n\n* BMI ≥ 27\n* Diagnosis of grade 1 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage\n* For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT\n* ECOG status \\\u003C2\n* Desire for fertility preservation\n* Ability to understand and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Evidence of myometrial invasion or extra-uterine disease on imaging\n* High grade or p53 mutated (p53mut) endometrial cancer\n* Estrogen receptor negative endometrial cancer (positivity defined as moderate\u002Fstrong staining\\>10%)\n* Mismatch repair deficient (MMRd) endometrial cancer\n* History of other malignancies except if curatively treated with no evidence of disease for \\>5 years\n* Previous surgical treatment of obesity\n* Current use of weight loss medication (no use in last 2 months)\n* Medical comorbidity with end-organ dysfunction\n* History of suicide attempts or current suicidal thoughts or behaviours\n* Currently taking insulin or insulin secretagogue (e.g., sulfonylurea)\n* Diabetic retinopathy\n* Gastroparesis or problems with food digestion\n* History of tachycardia (e.g., sinus tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, or ventricular tachycardia)\n* Contraindications to pIUD or semaglutide.\n\n  * Hypersensitive to WEGOVY or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container\n  * Personal or family history of medullary thyroid carcinoma (MTC)\n  * Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n  * Pregnant or breast-feeding\n  * Current or recurrent pelvic inflammatory disease\n  * Lower genital tract infection\n  * Postpartum endometritis\n  * Uterine anomalies including fibroids if they distort the uterine cavity\n  * Cervical malignancy\n  * Known or suspected progestin-dependent neoplasia, including breast cancer\n  * Cervicitis\n  * Untreated cervical dysplasia\n  * Active liver disease or dysfunction\n  * Actual benign or malignant liver tumors\n  * Sceptic abortion within the previous three months\n  * Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or components of MIRENA.\n  * Bacterial endocarditis\n  * Established immunodeficiency\n  * Acute malignancies affecting blood or leukemias\n  * Recent trophoblastic disease while hCG levels are elevated\n  * Previously inserted intrauterine device (IUD) that has not been removed\n  * Conditions associated with increased susceptibility to pelvic infections\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.","FEMALE","18 Years","41 Years",{"count":21,"type":22},71,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.",[28,29,30],"Endometrial Cancer","Atypical Hyperplasia","Fertility Perservation",[32,33,34,35,36,37],"pIUD","semaglutide","WEGOVY","atypical hyperplasia","endometrial cancer","fertility preservation","RECRUITING","2026-09-30",{"date":41,"type":42},"2026-10-05","ACTUAL",{"date":44,"type":42},"2026-09-17",{"date":46,"type":22},"2032-02",{"name":48,"class":49},"GynOncTrials","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100363157","bariatric-surgery-for-fertility-sparing-treatment-of-atypical-hyperplasia-and-grade-1-cancer-of-the-endometrium-100363157","NCT04008563","Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium","B-FiERCE","Inclusion Criteria:\n\n* BMI ≥ 35\n* Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia\n* Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)\n* ECOG status \\\u003C2\n* Desire for fertility preservation\n* No contraindications to progestin intrauterine device (IUD)\n* Have signed an approved informed consent form\n\nExclusion Criteria:\n\n* Evidence of myometrial invasion or extra-uterine disease on imaging\n* High grade or p53 endometrial cancer\n* History of other malignancies, except if curatively treated with no evidence of disease for \\> 5 years\n* Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion.\n* Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.\n* Contraindications to sleeve gastrectomy\n* Medical co-morbidity with end-organ dysfunction\n* Unable to understand and participate in the informed consent process\n* Currently pregnant\n* Active smoking in ≤6 months\n* Active substance use disorder\n* Current untreated or severe psychiatric issue",{"count":59,"type":22},36,[61],"NA","A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer\u002Fatypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.",[28,29,64],"Bariatric Surgery Candidate","2025-03-11",{"date":67,"type":42},"2025-03-14",{"date":69,"type":42},"2021-05-14",{"date":71,"type":22},"2027-03-31",{"name":73,"class":49},"University Health Network, Toronto"]