drugset / Trial / NCT04385667
LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized controlled trial is aimed to compare the efficacy between Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.
Timeline
- Start
- 2020-05-20
- Primary completion
- 2022-12-01
- Completion
- 2022-12-25
Publications
- Background Armstrong AJ, Hurd WW, Elguero S, Barker NM, Zanotti KM. Diagnosis and management of endometrial hyperplasia. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):562-71. doi: 10.1016/j.jmig.2012.05.009. Epub 2012 Aug 3.
- Background Salman MC, Usubutun A, Boynukalin K, Yuce K. Comparison of WHO and endometrial intraepithelial neoplasia classifications in predicting the presence of coexistent malignancy in endometrial hyperplasia. J Gynecol Oncol. 2010 Jun;21(2):97-101. doi: 10.3802/jgo.2010.21.2.97. Epub 2010 Jun 30.
- Background Zhou R, Yang Y, Lu Q, Wang J, Miao Y, Wang S, Wang Z, Zhao C, Wei L. Prognostic factors of oncological and reproductive outcomes in fertility-sparing treatment of complex atypical hyperplasia and low-grade endometrial cancer using oral progestin in Chinese patients. Gynecol Oncol. 2015 Dec;139(3):424-8. doi: 10.1016/j.ygyno.2015.09.078. Epub 2015 Sep 30.
- Background Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037.
- Alnemr AA, Harb OA, Atia H. The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e62. doi: 10.3802/jgo.2024.35.e62. Epub 2024 Feb 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Megestrol Acetate | Other / unclassified | 160 mg | Oral |