Impact of a new levonorgestrel intrauterine system, Levosert®, on heavy menstrual bleeding: results of a one-year randomised controlled trial. (June 2014)

• Record Type: Journal Article
• Authors: Mawet, Marie; Nollevaux, Fabrice; Nizet, Dominique; Wijzen, Fabienne; Gordenne, Valérie; Tasev, Niso; Segedi, Dimitrije; Marinescu, Bogdan; Enache, Andreea; Parhomenko, Vadim; Frankenne, Francis; Foidart, Jean-Michel
• Is Part Of: European journal of contraception & reproductive health care. Volume 19:Number 3(2014:Jun.)
• Page Start: 169
• Page End: 179
• Publication Date: 2014-06
• Subjects: Contraception -- Periodicals; Reproductive health -- Periodicals; Generative organs, Female -- Periodicals; Contraception -- Periodicals; Reproductive Medicine -- Periodicals; 613.9
• DOI: 10.3109/13625187.2014.894184
• Languages: English
• ISSNs: 1362-5187

Abstract

<abstract> <title>Abstract</title> <p> <bold>Objective</bold> To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert<sup>®</sup> for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena<sup>®</sup>.</p> <p> <bold>Methods</bold> 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<sup>®</sup> or Mirena<sup>®</sup> and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram.</p> <p> <bold>Results</bold> A total of 280 women were randomised (141 to Levosert<sup>®</sup> and 139 to Mirena<sup>®</sup>). During the one-year treatment period, both Levosert<sup>®</sup> and Mirena<sup>®</sup> dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert<sup>®</sup> and Mirena<sup>®</sup> regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert<sup>®</sup> was inserted with the same ease as Mirena<sup>®</sup>. Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group.</p> <p> <bold>Conclusion</bold> Levosert<sup>®</sup>, a new LNG-IUS designed to release the same daily amount of LNG as Mirena<sup>®</sup>, is highly effective in the treatment of HMB. No differences were observed between Levosert<sup>®</sup> and Mirena<sup>®</sup> regarding all evaluated outcomes, including safety profile.</p> </abstract>