Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

Ki vehet részt

• BMI ≥ 27
• Diagnosis of grade 1 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage
• 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
• ECOG status <2
• Desire for fertility preservation
• Ability to understand and willing to sign a written informed consent document

Ki nem vehet részt

• Previous surgical treatment of obesity
• Current use of weight loss medication (no use in last 2 months)
• Currently taking insulin or insulin secretagogue (e.g., sulfonylurea)
• Contraindications to pIUD or semaglutide; Hypersensitive to WEGOVY or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container; Personal or family history of medullary thyroid carcinoma (MTC); Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); Pregnant or breast-feeding; Current or recurrent pelvic inflammatory disease; Lower genital tract infection; Postpartum endometritis; Uterine anomalies including fibroids if they distort the uterine cavity; Cervical malignancy; Known or suspected progestin-dependent neoplasia, including breast cancer; Cervicitis; Untreated cervical dysplasia; Active liver disease or dysfunction; Actual benign or malignant liver tumors; Sceptic abortion within the previous three months; Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or components of MIRENA; Bacterial endocarditis; Established immunodeficiency; Acute malignancies affecting blood or leukemias; Recent trophoblastic disease while hCG levels are elevated; Previously inserted intrauterine device (IUD) that has not been removed; Conditions associated with increased susceptibility to pelvic infections
• Evidence of myometrial invasion or extra-uterine disease on imaging
• High grade or p53 mutated (p53mut) endometrial cancer
• Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining>10%)
• Mismatch repair deficient (MMRd) endometrial cancer
• History of suicide attempts or current suicidal thoughts or behaviours
• History of tachycardia (e.g., sinus tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, or ventricular tachycardia)
• 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
• History of other malignancies except if curatively treated with no evidence of disease for >5 years
• Medical comorbidity with end-organ dysfunction
• Diabetic retinopathy
• Gastroparesis or problems with food digestion