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NCT07890064

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

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Complete remission (CR) rate of endometrial lesions at 24 weeks
Timeframe: 24 weeks after treatment initiation

Secondary (8)

Complete remission (CR) rate of endometrial lesions at 12 weeks
Time to achieve complete remission (CR)
Cumulative CR rate
Recurrence-free rate among participants achieving CR
Recurrence-free interval among participants achieving CR
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Pregnancy rate
live birth rate
Incidence of adverse events (AEs) and serious adverse events (SAEs)

Arms and interventions

LNG-IUSPlacebo comparator

Participants receiving LNG-IUS only.

LNG-IUS+MetforminExperimental

Participants received LNG-IUS combined with oral metformin at 1000-2000 mg/day.

LNG-IUS+canagliflozinExperimental

Participants received LNG-IUS combined with oral canagliflozin 100 mg once daily.

Drugs: LNG-IUS: levonorgestrel intrauterine system, Metformin, Canagliflozin

Sites

1 site in 1 country

  • Tianjin Medical University General HospitalTianjin, Tianjin Municipality, China