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NOT YET RECRUITING
NCT07890064
PHASE2

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

Sponsor: Wang Yingmei

View on ClinicalTrials.gov

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

DRUG

LNG-IUS: levonorgestrel intrauterine system

Participants receiving LNG-IUS

DRUG

Metformin

oral metformin at 1000-2000 mg/day.

DRUG

Canagliflozin

oral canagliflozin 100 mg once daily

Locations (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China