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

BJOG. 2014 Mar;121(4):477-86. doi: 10.1111/1471-0528.12499. Epub 2013 Nov 28.


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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Contraceptives, Oral, Synthetic / therapeutic use*
  • Drug Administration Schedule
  • Endometrial Hyperplasia / drug therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Intrauterine Devices, Medicated*
  • Levonorgestrel / therapeutic use*
  • Medroxyprogesterone / therapeutic use
  • Middle Aged
  • Norway
  • Progestins / therapeutic use*
  • Risk
  • Single-Blind Method
  • Treatment Outcome


  • Contraceptives, Oral, Synthetic
  • Progestins
  • Levonorgestrel
  • Medroxyprogesterone

Associated data

  • ClinicalTrials.gov/NCT01074892