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

Authors

  • A Ørbo,

    Corresponding author
    1. Department of Clinical Pathology, University Hospital of North Norway, Tromsø, Norway
    2. Research group for Gynaecological Cancer, Department of Medical Biology, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway
    • Correspondence: Prof. A Ørbo, Department of Clinical Pathology, University Hospital of North Norway, N-9038 Tromsø,

      and Research Group for Gynaecologic Cancer, Department of Medical Biology, Faculty of Health Sciences, University of Tromsø, N-9037 Tromsø, Norway. Email anne.orbo@uit.no

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  • AB Vereide,

    1. Department of Gynaecological Oncology, Clinic for Surgery, Cancer and Women's Disease, University Hospital of North Norway, Tromsø, Norway
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  • M Arnes,

    1. Research group for Gynaecological Cancer, Department of Medical Biology, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway
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  • I Pettersen,

    1. Department of Clinical Pathology, University Hospital of North Norway, Tromsø, Norway
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  • B Straume

    1. Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway
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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.

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