Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

Summary

Primary end points: This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome. Second end points: To analyze the appearances of side-effects.

Timeline

Start

2018-04-01

Primary completion

2025-12-30

Completion

2030-12-30

Publications

• Background Ushijima K, Yahata H, Yoshikawa H, Konishi I, Yasugi T, Saito T, Nakanishi T, Sasaki H, Saji F, Iwasaka T, Hatae M, Kodama S, Saito T, Terakawa N, Yaegashi N, Hiura M, Sakamoto A, Tsuda H, Fukunaga M, Kamura T. Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women. J Clin Oncol. 2007 Jul 1;25(19):2798-803. doi: 10.1200/JCO.2006.08.8344.
• Background Rodolakis A, Biliatis I, Morice P, Reed N, Mangler M, Kesic V, Denschlag D. European Society of Gynecological Oncology Task Force for Fertility Preservation: Clinical Recommendations for Fertility-Sparing Management in Young Endometrial Cancer Patients. Int J Gynecol Cancer. 2015 Sep;25(7):1258-65. doi: 10.1097/IGC.0000000000000493.
• Background Minig L, Franchi D, Boveri S, Casadio C, Bocciolone L, Sideri M. Progestin intrauterine device and GnRH analogue for uterus-sparing treatment of endometrial precancers and well-differentiated early endometrial carcinoma in young women. Ann Oncol. 2011 Mar;22(3):643-649. doi: 10.1093/annonc/mdq463. Epub 2010 Sep 28.
• Background KELLEY RM, BAKER WH. Progestational agents in the treatment of carcinoma of the endometrium. N Engl J Med. 1961 Feb 2;264:216-22. doi: 10.1056/NEJM196102022640503. No abstract available.
• Background Zhang Q, Qi G, Kanis MJ, Dong R, Cui B, Yang X, Kong B. Comparison among fertility-sparing therapies for well differentiated early-stage endometrial carcinoma and complex atypical hyperplasia. Oncotarget. 2017 May 3;8(34):57642-57653. doi: 10.18632/oncotarget.17588. eCollection 2017 Aug 22.
• Background Wildemeersch D, Andrade A, Goldstuck N. Femilis((R)) 60 Levonorgestrel-Releasing Intrauterine System-A Review of 10 Years of Clinical Experience. Clin Med Insights Reprod Health. 2016 Aug 9;10:19-27. doi: 10.4137/CMRH.S40087. eCollection 2016.
• Background Karimi-Zarchi M, Dehghani-Firoozabadi R, Tabatabaie A, Dehghani-Firoozabadi Z, Teimoori S, Chiti Z, Miratashi-Yazdi A, Dehghani A. A comparison of the effect of levonorgestrel IUD with oral medroxyprogesterone acetate on abnormal uterine bleeding with simple endometrial hyperplasia and fertility preservation. Clin Exp Obstet Gynecol. 2013;40(3):421-4.
• 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.
• Background Orbo A, Vereide A, Arnes M, Pettersen I, Straume B. Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial. BJOG. 2014 Mar;121(4):477-86. doi: 10.1111/1471-0528.12499. Epub 2013 Nov 28.
• Background Kim MK, Seong SJ, Kim JW, Jeon S, Choi HS, Lee IH, Lee JH, Ju W, Song ES, Park H, Ryu HS, Lee C, Kang SB. Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System: A Korean Gynecologic-Oncology Group Study. Int J Gynecol Cancer. 2016 May;26(4):711-5. doi: 10.1097/IGC.0000000000000669.
• Background Practice Bulletin No. 149: Endometrial cancer. Obstet Gynecol. 2015 Apr;125(4):1006-1026. doi: 10.1097/01.AOG.0000462977.61229.de. No abstract available.
• Background Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO consensus conference on endometrial cancer: Diagnosis, treatment and follow-up. Radiother Oncol. 2015 Dec;117(3):559-81. doi: 10.1016/j.radonc.2015.11.013. Epub 2015 Dec 9.
• Background Lee SW, Lee TS, Hong DG, No JH, Park DC, Bae JM, Seong SJ, Shin SJ, Ju W, Lee KH, Lee YK, Cho H, Lee C, Paek J, Kim HJ, Lee JW, Kim JW, Bae DS. Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement. J Gynecol Oncol. 2017 Jan;28(1):e12. doi: 10.3802/jgo.2017.28.e12. Epub 2016 Oct 27.
• Background Denny L, Quinn M. FIGO Cancer Report 2015. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 2:S75. doi: 10.1016/j.ijgo.2015.06.024. No abstract available.
• Background The American College of Obstetricians and Gynecologists Committee Opinion no. 631. Endometrial intraepithelial neoplasia. Obstet Gynecol. 2015 May;125(5):1272-1278. doi: 10.1097/01.AOG.0000465189.50026.20.
• Background Chinese Medical Association Department of Gynecologic Oncology., Guidelines on Clinical Fertility-Sparing Treatment of Gynecologic Cancer. Chinese Journal of OBsterics and Gynecology, 2014(4):9-9
• Background NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Uterine Neoplasms. Version 2.2017 - April 25, 2017. NCCN.org
• Background Guidelines on Clinical Management of Endometrial Hyperplasia. HKCOG GUIDELINES NUMBER 631 (May 2015)
• Background Reproductive endocrinology group of China Health Industry Management Association for maternal and child health industry branch. consensus conference on endometrial hyperplasia: Diagnosis, treatment and follow-up. Journal of Reproductive Medicine. 2017. 26(10): p. 957-959.
• Background Ebina Y, Katabuchi H, Mikami M, Nagase S, Yaegashi N, Udagawa Y, Kato H, Kubushiro K, Takamatsu K, Ino K, Yoshikawa H. Japan Society of Gynecologic Oncology guidelines 2013 for the treatment of uterine body neoplasms. Int J Clin Oncol. 2016 Jun;21(3):419-34. doi: 10.1007/s10147-016-0981-1. Epub 2016 Apr 26.
• Background Royal College of Obstetricians and Gynaecologists (RCOG) with the British Society for Gynaecological Endoscopy (BSGE). Management of Endometrial Hyperplasia. Green-top Guideline No. 67. RCOG/BSGE Joint Guideline. London; 2016 (cited 29 March 2016).
• Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.

Drugs

Indications