Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial

A Orbo, Ab Vereide, M Arnes, I Pettersen, B Straume, A Orbo, Ab Vereide, M Arnes, I Pettersen, B Straume

Abstract

Objective: The purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device (LNG-IUS, Mirena(®) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone (MPA).

Design: A multicentre randomised trial.

Setting: Norway.

Population: In all, 170 women aged 30-70 years with low- or medium-risk endometrial hyperplasia who met inclusion criteria.

Methods: Patients were randomly assigned to one of three treatment arms: LNG-IUS; oral MPA 10 mg administered for 10 days per cycle, or continuous oral MPA 10 mg daily, for 6 months.

Main outcome measures: The primary outcome measure was normalisation or persisting hyperplasia.

Results: After 6 months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not (P < 0.001). Responses were obtained for all the women in the LNG-IUS group (53/53, 95% CI 0.93-1.0) and for 96% of the women in the continuous oral group (46/48, 95% CI 0.86-0.99). Only 69% of the women in the cyclic oral group were responders (36/52, 95% CI 0.55-0.81). Adverse effects were relatively common with minimal differences between therapy groups.

Conclusion: In the first trial of its kind, women treated with the LNG-IUS showed histologically normal endometrium after 6 months of therapy for endometrial hyperplasia. Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose.

Trial registration: ClinicalTrials.gov NCT01074892.

Keywords: Endometrial hyperplasia; levonorgestrel-impregnated intrauterine device versus oral progestin; therapy.

© 2013 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Figures

Figure 1
Figure 1
Flow diagram for the study.

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