A Phase 2 interventional study of LNG-IUS: levonorgestrel intrauterine system and Metformin in Endometrioid Endometrial Cancer and Atypical Endometrial Hyperplasia, sponsored by Wang Yingmei. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Wang Yingmei · Phase 2, Interventional, and Treatment
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.
105 studies on the registry are indexed under Endometrial Hyperplasia; 36 are open to participants now.
This study's planned enrollment of 102 is above the median of 76 across 66 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →This is the only study on the registry with Wang Yingmei as lead sponsor.
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Exclusion Criteria:
Participants receiving LNG-IUS only.
Drug: LNG-IUS: levonorgestrel intrauterine system
Participants received LNG-IUS combined with oral metformin at 1000-2000 mg/day.
Drug: LNG-IUS: levonorgestrel intrauterine system · Drug: Metformin
Participants received LNG-IUS combined with oral canagliflozin 100 mg once daily.
Drug: LNG-IUS: levonorgestrel intrauterine system · Drug: Canagliflozin
Participants receiving LNG-IUS
oral metformin at 1000-2000 mg/day.
oral canagliflozin 100 mg once daily
Complete remission (CR) rate of endometrial lesions at 24 weeks
Time frame: 24 weeks after treatment initiation
Complete remission (CR) rate of endometrial lesions at 12 weeks
Time frame: 12 weeks after treatment initiation
Time to achieve complete remission (CR)
Time frame: From treatment initiation up to 2 years
Cumulative CR rate
Time frame: From treatment initiation up to 2 years
Recurrence-free rate among participants achieving CR
Time frame: From achievement of CR up to 2 years
Recurrence-free interval among participants achieving CR
Time frame: From achievement of CR up to 2 years
Pregnancy rate
Assessed among participants attempting pregnancy during the 2-year follow-up period.
Time frame: From achievement of CR up to 2 years
live birth rate
Assessed among participants attempting pregnancy during the 2-year follow-up period.
Time frame: From achievement of CR up to 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From treatment initiation to completion
Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Metformin · Canagliflozin