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Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Sponsor: Wang Yingmei
Summary
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.
Official title: A Prospective Randomized Controlled Trial of Canagliflozin Combined With Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Carcinoma
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2027-01-01
Completion Date
2031-12-31
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
LNG-IUS: levonorgestrel intrauterine system
Participants receiving LNG-IUS
Metformin
oral metformin at 1000-2000 mg/day.
Canagliflozin
oral canagliflozin 100 mg once daily
Locations (1)
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China