title: A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia.
abstract: OBJECTIVE
  To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia.
  
  
  METHODS
  A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months. The primary endpoint was the change in MBL from baseline to 12 months. Secondary endpoints included treatment success (defined as a MBL score < 100 after 12 months), hemoglobin levels, and the menorrhagia severity score.
  
  
  RESULTS
  In both treatment groups, MBL decreased significantly from baseline to 12 months (P < 0.001). For the primary endpoint, the MBL score decreased significantly more in the LNG-IUS group (median from 228 to 13, mean percent change-83%) compared to the OC1/20 group (median from 290 to 72; mean percent change-68%) (P = 0.002) after 12 months. In the LNG-IUS group, 80% of subjects had treatment success compared with 36.8 % in the OC1/20 group (P < 0.009). Both treatments increased hemoglobin concentrations significantly between baseline and 12 months. The menorrhagia severity score was consistently lower in the LNG-IUS group at all study time points and was significantly lower (P = 0.045) at six months. Both treatments were well tolerated.
  
  
  CONCLUSIONS
  Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.
authors.affiliation: Bayer Inc., Toronto ON; Universitätskliniken des Saarlandes, Frauenklinik, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
authors.affiliation: University of Toronto, Mount Sinai Hospital, Toronto ON.
authors.forename: Heather
authors.initials: H
authors.lastname: Shapiro
authors.affiliation: Bayer Schering Pharma Oy, Espoo, Finland.
authors.forename: Eeva
authors.initials: E
authors.lastname: Lukkari-Lax
authors.affiliation: Bayer Schering Pharma AG, Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kunz
authors.affiliation: Universitätskliniken des Saarlandes, Frauenklinik, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Schmidt
authors.affiliation: Clinique de Recherche en Santé des Femmes, Obstetrics and Gynecology, Quebec City QC.
authors.forename: Michel
authors.initials: M
authors.lastname: Fortier
mesh_terms: D000328:Adult; D002170:Canada; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D003280:Contraceptives, Oral, Synthetic / Q000627:therapeutic use; D004967:Estrogens / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000627:therapeutic use; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000188:drug therapy*; D009640:Norethindrone / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D011446:Prospective Studies; D012720:Severity of Illness Index
chemical_list: D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D006454:Hemoglobins; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D000077563:Norethindrone Acetate; D009640:Norethindrone