Comparison of Efficacy Between Levonorgestrel Intrauterine System and Dienogest in Adenomyosis: a Randomized Clinical Trial

Overview

Journal Ther Adv Reprod Health

Publisher Sage Publications

Specialty Reproductive Medicine

Date 2024 Jan 29

PMID 38283750

Authors

Satish Choudhury

Saubhagya Kumar Jena

Subarna Mitra

Biswa Mohan Padhy

Sudipta Mohakud

Affiliations

Soon will be listed here.

Abstract

Background: Medical management of adenomyosis is an emerging perspective in modern gynecology. Though levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG) effectively relieve symptoms in adenomyosis, neither has been approved for the same indication. Our study aims to compare the efficacy and safety of these progestins in treating adenomyosis.

Objective: To study the efficacy and safety of LNG-IUS DNG in patients with symptomatic adenomyosis.

Design: Open-labeled, parallel, single-centered, randomized clinical trial.

Methods: Patients with adenomyosis-associated pain with or without abnormal uterine bleeding were randomly allocated to either LNG-IUS group or DNG group. The primary outcome was a reduction in painful symptoms after 12 weeks of treatment measured by visual analog scale (VAS) score. Changes in menstrual blood loss (MBL), improvement in quality of life (QoL), and adverse drug reactions were also analyzed.

Results: The VAS score significantly decreased from baseline in both groups. The baseline and post-treatment VAS scores in the LNG-IUS group were 6.41 ± 1.07 and 3.41 ± 1.04 ( = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 ( = <0.001), respectively. A significantly greater proportion of patients in the LNG-IUS group experienced lighter MBL as compared to the DNG group [27/30 (90%) in the LNG-IUS group 17/22 (77.2%) in the DNG group ( = 0.006)]. Both the groups had improvement in QOL scores calculated by the World Heath Organisation QOL scale (WHOQOL BREF) questionnaire; however, it was more pronounced in the DNG group [(28.76 ± 30.47 in the LNG-IUS group 48.26 ± 44.91 in the DNG group ( = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.

Conclusion: DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.

Trial Registration: The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.

Citing Articles

The Role of Different Medical Therapies in the Management of Adenomyosis: A Systematic Review and Meta-Analysis.

Galati G, Ruggiero G, Grobberio A, Capri O, Pietrangeli D, Recine N J Clin Med. 2024; 13(11).

PMID: 38893013 PMC: 11172524. DOI: 10.3390/jcm13113302.

References

Fawzy M, Mesbah Y . Comparison of dienogest versus triptorelin acetate in premenopausal women with adenomyosis: a prospective clinical trial. Arch Gynecol Obstet. 2015; 292(6):1267-71. DOI: 10.1007/s00404-015-3755-5. View

Hassanin A, Youssef A, Yousef A, Ali M . Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021; 154(2):263-269. DOI: 10.1002/ijgo.13600. View

Ozdegirmenci O, Kayikcioglu F, Akgul M, Kaplan M, Karcaaltincaba M, Haberal A . Comparison of levonorgestrel intrauterine system versus hysterectomy on efficacy and quality of life in patients with adenomyosis. Fertil Steril. 2010; 95(2):497-502. DOI: 10.1016/j.fertnstert.2010.10.009. View

Guo S, Mao X, Ma Q, Liu X . Dysmenorrhea and its severity are associated with increased uterine contractility and overexpression of oxytocin receptor (OTR) in women with symptomatic adenomyosis. Fertil Steril. 2012; 99(1):231-240. DOI: 10.1016/j.fertnstert.2012.08.038. View

Hirata T, Izumi G, Takamura M, Saito A, Nakazawa A, Harada M . Efficacy of dienogest in the treatment of symptomatic adenomyosis: a pilot study. Gynecol Endocrinol. 2014; 30(10):726-9. DOI: 10.3109/09513590.2014.926882. View

Ota K, Takahashi T, Shiraishi S, Mizunuma H . Combination of microwave endometrial ablation and postoperative dienogest administration is effective for treating symptomatic adenomyosis. J Obstet Gynaecol Res. 2018; 44(9):1787-1792. DOI: 10.1111/jog.13720. View

Shaaban O, Ali M, Sabra A, Abd El Aal D . Levonorgestrel-releasing intrauterine system versus a low-dose combined oral contraceptive for treatment of adenomyotic uteri: a randomized clinical trial. Contraception. 2015; 92(4):301-7. DOI: 10.1016/j.contraception.2015.05.015. View

Altshuler A, Gaffield M, Kiarie J . The WHO's medical eligibility criteria for contraceptive use: 20 years of global guidance. Curr Opin Obstet Gynecol. 2015; 27(6):451-9. PMC: 5703409. DOI: 10.1097/GCO.0000000000000212. View

Munro M, Critchley H, Fraser I . The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. Int J Gynaecol Obstet. 2018; 143(3):393-408. DOI: 10.1002/ijgo.12666. View

10.

Matsushima T, Akira S, Yoneyama K, Takeshita T . Recurrence of uterine adenomyosis after administration of gonadotropin-releasing hormone agonist and the efficacy of dienogest. Gynecol Endocrinol. 2019; 36(6):521-524. DOI: 10.1080/09513590.2019.1683818. View

11.

Nagata C, Yanagida S, Okamoto A, Morikawa A, Sugimoto K, Okamoto S . Risk factors of treatment discontinuation due to uterine bleeding in adenomyosis patients treated with dienogest. J Obstet Gynaecol Res. 2012; 38(4):639-44. DOI: 10.1111/j.1447-0756.2011.01778.x. View

12.

Li Q, Yuan M, Li N, Zhen Q, Chen C, Wang G . The efficacy of medical treatment for adenomyosis after adenomyomectomy. J Obstet Gynaecol Res. 2020; 46(10):2092-2099. DOI: 10.1111/jog.14376. View

13.

McCormack P . Dienogest: a review of its use in the treatment of endometriosis. Drugs. 2010; 70(16):2073-88. DOI: 10.2165/11206320-000000000-00000. View

14.

Ota I, Taniguchi F, Ota Y, Nagata H, Wada I, Nakaso T . A controlled clinical trial comparing potent progestins, LNG-IUS and dienogest, for the treatment of women with adenomyosis. Reprod Med Biol. 2021; 20(4):427-434. PMC: 8499603. DOI: 10.1002/rmb2.12408. View

15.

Bragheto A, Caserta N, Bahamondes L, Petta C . Effectiveness of the levonorgestrel-releasing intrauterine system in the treatment of adenomyosis diagnosed and monitored by magnetic resonance imaging. Contraception. 2007; 76(3):195-9. DOI: 10.1016/j.contraception.2007.05.091. View

16.

Osuga Y, Fujimoto-Okabe H, Hagino A . Evaluation of the efficacy and safety of dienogest in the treatment of painful symptoms in patients with adenomyosis: a randomized, double-blind, multicenter, placebo-controlled study. Fertil Steril. 2017; 108(4):673-678. DOI: 10.1016/j.fertnstert.2017.07.021. View

17.

Neriishi K, Hirata T, Fukuda S, Izumi G, Nakazawa A, Yamamoto N . Long-term dienogest administration in patients with symptomatic adenomyosis. J Obstet Gynaecol Res. 2018; 44(8):1439-1444. DOI: 10.1111/jog.13674. View

18.

Beatty M, Blumenthal P . The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability. Ther Clin Risk Manag. 2009; 5(3):561-74. PMC: 2724187. DOI: 10.2147/tcrm.s5624. View

19.

Levy G, Dehaene A, Laurent N, Lernout M, Collinet P, Lucot J . An update on adenomyosis. Diagn Interv Imaging. 2012; 94(1):3-25. DOI: 10.1016/j.diii.2012.10.012. View

20.

Abbas A, Samy A, Atwa K, Ghoneim H, Lotfy M, Mohammed H . The role of levonorgestrel intra-uterine system in the management of adenomyosis: A systematic review and meta-analysis of prospective studies. Acta Obstet Gynecol Scand. 2020; 99(5):571-581. DOI: 10.1111/aogs.13798. View