FPIN's Help Desk Answers

Levonorgestrel-Releasing Intrauterine System vs. Oral Progestins for Treatment of Endometrial Hyperplasia


Am Fam Physician. 2016 Jun 1;93(11):948-949.

Clinical Question

In women with endometrial hyperplasia without atypia, is the levonorgestrel-releasing intrauterine system (Mirena) or oral progestin therapy more effective in achieving complete resolution?

Evidence-Based Answer

The levonorgestrel-releasing intrauterine system achieves significantly higher resolution rates of endometrial hyperplasia without atypia compared with cyclic oral progestins (68% to 100% vs. 48% to 69%, respectively). (Strength of Recommendation [SOR]: A, based on consistent randomized controlled trials [RCTs].) Treatment with continuous oral progestins for six months is also more effective than cyclic progestins (96% vs. 69%) and is comparable to the levonorgestrel-releasing intrauterine system. (SOR: B, based on an RCT.)

Researchers randomized 120 premenopausal women with abnormal uterine bleeding and non-atypical simple or complex endometrial hyperplasia to receive a levonorgestrel-releasing intrauterine system (n = 59) or oral norethindrone (n = 61).1 Endometrial hyperplasia was initially diagnosed by dilation and curettage; endometrial biopsy was performed for follow-up. Women in the norethindrone group received 5 mg three times per day, for three weeks per month, for three consecutive months. Treatment was continued for three or six additional months if patients did not have complete resolution. The levonorgestrel-releasing intrauterine system remained in place for the duration of the study (12 months). Compared with those in the norethindrone group, more women in the levonorgestrel group achieved complete resolution at three months (68% vs. 48%; relative risk [RR] = 1.4; 95% confidence interval [CI], 1.0 to 2.0), six months (80% vs. 61%; RR = 1.3; 95% CI, 1.0 to 1.7), and 12 months (88% vs. 55%; RR = 1.6; 95% CI, 1.2 to 2.0). This study was limited by lack of patient blinding. However, the pathologist who read the histologic surveillance was blinded to the treatment modality.

In another RCT, 104 pre- and post-menopausal women with abnormal uterine

Address correspondence to Sarah Liegl, MD, at sarahliegl@centura.org. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.


1. Abu Hashim H, Zayed A, Ghayaty E, El Rakhawy M. LNG-IUS treatment of non-atypical endometrial hyperplasia in perimenopausal women: a randomized controlled trial. J Gynecol Oncol. 2013;24(2):128–134.

2. Dolapcioglu K, Boz A, Baloglu A. The efficacy of intrauterine versus oral progestin for the treatment of endometrial hyperplasia. A prospective randomized comparative study. Clin Exp Obstet Gynecol. 2013;40(1):122–126.

3. 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;121(4):477–486.

Help Desk Answers provides answers to questions submitted by practicing family physicians to the Family Physicians Inquiries Network (FPIN). Members of the network select questions based on their relevance to family medicine. Answers are drawn from an approved set of evidence-based resources and undergo peer review.

The complete database of evidence-based questions and answers is copyrighted by FPIN. If interested in submitting questions or writing answers for this series, go to http://www.fpin.org or e-mail: questions@fpin.org.

This series is coordinated by John E. Delzell Jr., MD, MSPH, Assistant Medical Editor.



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