Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer

This study aims to evaluate whether the addition of canagliflozin to levonorgestrel-releasing intrauterine system (LNG-IUS) treatment, as compared with matching placebo or with the addition of metformin, increases the rate of pathological complete response (CR) at Week 24 in patients who wish to preserve fertility and who are overweight or have impaired glucose tolerance, type 2 diabetes mellitus, or polycystic ovary syndrome, with a diagnosis of atypical endometrial hyperplasia (AEH) or early-stage endometrioid endometrial carcinoma. The safety of this regimen and its effects on body weight, metabolic parameters, fertility, and long-term disease outcomes will also be assessed.