title: Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial.
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).
  
  
  METHODS
  A multicentre randomised trial.
  
  
  METHODS
  Norway.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Clinical Pathology, University Hospital of North Norway, Tromsø, Norway; Research group for Gynaecological Cancer, Department of Medical Biology, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Orbo
authors.forename: Ab
authors.initials: A
authors.lastname: Vereide
authors.forename: M
authors.initials: M
authors.lastname: Arnes
authors.forename: I
authors.initials: I
authors.lastname: Pettersen
authors.forename: B
authors.initials: B
authors.lastname: Straume
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003280:Contraceptives, Oral, Synthetic / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004714:Endometrial Hyperplasia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000627:therapeutic use*; D008525:Medroxyprogesterone / Q000627:therapeutic use; D008875:Middle Aged; D009664:Norway; D011372:Progestins / Q000627:therapeutic use*; D012306:Risk; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D003280:Contraceptives, Oral, Synthetic; D011372:Progestins; D016912:Levonorgestrel; D008525:Medroxyprogesterone
keywords: Endometrial hyperplasia; levonorgestrel-impregnated intrauterine device versus oral progestin; therapy