drugset / Trial / NCT04607252

Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

NCT04607252 ↗

Phase 2/3 Terminated 12 enrolled Fudan University
RandomizedParallel-groupDouble-blindTreatment

Summary

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Timeline

Start
2021-01-11
Primary completion
2021-06-03
Completion
2021-06-03

Outcome

Outcome not reported

Stopped: “Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Megestrol Acetate Other / unclassified 160 mg Oral
Subject Metformin Small molecule 1500 mg Oral