A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

Phase 2 Unknown 60 enrolled KK Women's and Children's Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.

Timeline

Start: 2020-01-03
Primary completion: 2023-03-31
Completion: 2023-03-31

Outcome

Met primary endpoint

paper LNG-IUS is a non-inferior treatment compared to megestrol acetate. PMID 39215793 ↗

Publications

Goh CSY, Loh MJM, Lim WW, Ang JX, Nadarajah R, Yong TT, Tong P, Yeo YC, Phoon JWL. A multi-centre randomised controlled trial comparing megestrol acetate to levonorgestrel-intrauterine system in fertility sparing treatment of atypical endometrial hyperplasia. J Assist Reprod Genet. 2024 Sep;41(9):2485-2494. doi: 10.1007/s10815-024-03172-z. Epub 2024 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	52 mg	Other
Subject	Megestrol Acetate	Other / unclassified	160 mg	Oral