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

Objective To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert (R) for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena (R). 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 (R) or Mirena (R) 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 (R) and 139 to Mirena (R)). During the one-year treatment period, both Levosert (R) and Mirena (R) dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert (R) and Mirena (R) regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert (R) was inserted with the same ease as Mirena (R). Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group. Conclusion Levosert (R), a new LNG-IUS designed to release the same daily amount of LNG as Mirena (R), is highly effective in the treatment of HMB. No differences were observed between Levosert (R) and Mirena (R) regarding all evaluated outcomes, including safety profile.