title: Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial.
abstract: OBJECTIVE
  To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert(®) for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena(®).
  
  
  METHODS
  A multicentre, randomised, controlled trial, in non-menopausal women diagnosed with functional HMB (defined as menstrual blood loss [MBL] ≥ 80 mL) randomised to either Levosert(®) or Mirena(®) and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram.
  
  
  RESULTS
  A total of 280 women were randomised (141 to Levosert(®) and 139 to Mirena(®)). During the one-year treatment period, both Levosert(®) and Mirena(®) dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert(®) and Mirena(®) regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert(®) was inserted with the same ease as Mirena(®). Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group.
  
  
  CONCLUSIONS
  Levosert(®), a new LNG-IUS designed to release the same daily amount of LNG as Mirena(®), is highly effective in the treatment of HMB. No differences were observed between Levosert(®) and Mirena(®) regarding all evaluated outcomes, including safety profile.
authors.affiliation: * Uteron Pharma Sprl, Grace-Hollogne , Belgium.
authors.forename: Marie
authors.initials: M
authors.lastname: Mawet
authors.forename: Fabrice
authors.initials: F
authors.lastname: Nollevaux
authors.forename: Dominique
authors.initials: D
authors.lastname: Nizet
authors.forename: Fabienne
authors.initials: F
authors.lastname: Wijzen
authors.forename: Valérie
authors.initials: V
authors.lastname: Gordenne
authors.forename: Niso
authors.initials: N
authors.lastname: Tasev
authors.forename: Dimitrije
authors.initials: D
authors.lastname: Segedi
authors.forename: Bogdan
authors.initials: B
authors.lastname: Marinescu
authors.forename: Andreea
authors.initials: A
authors.lastname: Enache
authors.forename: Vadim
authors.initials: V
authors.lastname: Parhomenko
authors.forename: Francis
authors.initials: F
authors.lastname: Frankenne
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Foidart
mesh_terms: D000328:Adult; D001810:Blood Volume; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage*; D005260:Female; D005293:Ferritins / Q000097:blood; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007433:Intrauterine Device Expulsion; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000097:blood / Q000188:drug therapy*; D016037:Single-Blind Method
chemical_list: D003280:Contraceptives, Oral, Synthetic; D006454:Hemoglobins; D016912:Levonorgestrel; D005293:Ferritins
keywords: Heavy menstrual bleeding; Intrauterine system; Levonorgestrel; Levosert®; Mirena®