title: A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.
abstract: OBJECTIVE
  To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) with that of a low-dose combined oral contraceptive (COC) in reducing fibroid-related menorrhagia.
  
  
  METHODS
  In this single-center, open, randomized clinical trial, 58 women with menorrhagia who desired contraception were randomized to receive a LNG-IUS or COC. The outcomes included treatment failure, defined as the need for another treatment; menstrual blood loss (MBL) by the alkaline hematin method and a pictorial assessment chart (PBAC); hemoglobin levels; and "lost days."
  
  
  RESULTS
  Treatment failed in 6 women (23.1%) in the LNG-IUS group and 11 (37.9%) in the COC group, for a hazard ratio of 0.46 (95% CI, 0.17-1.17, P=0.101). Using the alkaline hematin test, the reduction of MBL was significantly greater in the LNG-IUS group (90.9% ± 12.8% vs 13.4% ± 11.1%; P<0.001). Using PBAC scores, the reduction was also significantly greater in the LNG-IUS group (88.0% ± 16.5% vs 53.5% ± 5 1.2%; P=0.02). Moreover, hemoglobin levels increased from 9.7 ± 1.9g/dL to 11.7 ± 1.2g/dL (P<0.001) and lost days decreased from 8.2 ± 3.3 days to 1.3 ± 1.5 days (P=0.003) in the LNG-IUS group.
  
  
  CONCLUSIONS
  Although the rate of treatment failure was similar in both groups, the LNG-IUS was more effective in reducing MBL than the COC in women with fibroid-related menorrhagia.
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Gamal H
authors.initials: GH
authors.lastname: Sayed
authors.forename: Mahmoud S
authors.initials: MS
authors.lastname: Zakherah
authors.forename: Sherif A
authors.initials: SA
authors.lastname: El-Nashar
authors.forename: Mamdouh M
authors.initials: MM
authors.lastname: Shaaban
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007436:Intrauterine Devices, Medicated; D007889:Leiomyoma / Q000150:complications*; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000188:drug therapy* / Q000209:etiology; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D006454:Hemoglobins; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel