ObjectiveThe 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).DesignA multicentre randomised trial.SettingNorway.PopulationIn all, 170 women aged 30–70 years with low- or medium-risk endometrial hyperplasia who met inclusion criteria.MethodsPatients 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 measuresThe primary outcome measure was normalisation or persisting hyperplasia.ResultsAfter 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.ConclusionIn 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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ObjectiveTo investigate relapse rates after the successful treatment of patients with non‐atypical endometrial hyperplasia who were randomised to either a levonorgestrel‐impregnated intrauterine system (LNG‐IUS; Mirena®) or two regimens of oral medroxyprogesterone acetate (MPA) after primary histological response.DesignA multicentre randomised trial.SettingTen different outpatient clinics localised in hospitals and seven gynaecological private practices in Norway.PopulationOne hundred and fifty‐three women aged 30–70 years with low‐ or medium‐risk endometrial hyperplasia met the inclusion criteria, and 153 completed the therapy.MethodsPatients were randomly assigned to one of the following three treatment arms: LNG‐IUS; 10 mg of oral MPA administered for 10 days per cycle for 6 months; or 10 mg of oral MPA administered daily for 6 months. The women were followed for 24 months after ending therapy.Main outcome measuresHistological relapse of endometrial hyperplasia.ResultsHistological relapse was observed in 55/135 (41%) women who had an initial complete treatment response. The relapse rates were similar in the three therapy groups (P = 0.66). In the multivariable analyses relapse was dependent on menopausal status (P = 0.0005) and estrogen level (P = 0.0007).ConclusionsThe risk of histological relapse of non‐atypical endometrial hyperplasia is high within 24 months of ceasing therapy with either the LNG‐IUS or oral MPA. Continued endometrial surveillance and prolonging progestogen therapy should be considered.Tweetable abstractRelapse of endometrial hyperplasia after successful treatment is independent of therapy regime.

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