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

Korábbi kezelés

• 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

Más betegség

• 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.

Életkor

• History of other malignancies except if curatively treated with no evidence of disease for >5 years

Egyéb

• Medical comorbidity with end-organ dysfunction
• Diabetic retinopathy
• Gastroparesis or problems with food digestion

• 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