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

Abstract

ObjectiveTo 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®.MethodsA 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.ResultsA 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.ConclusionLevosert®, 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.

Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

“…Most expulsions occurred in the first year, consistent with expulsion timing seen with other IUDs [16][17][18]. A similar expulsion rate (4.2%) was reported in a European study to evaluate the safety and efficacy of LNG20 (under the brand name Levosert™) in women with menorrhagia [19]. Expulsions occurred more frequently in parous participants, which may partly account for the lower overall expulsion rate as this study had relatively fewer parous participants.…”

“…16 Data presented as n (%) or mean ± standard deviation. ⁎ Data missing for four [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] year old participants. IUS = intrauterine system; IUD = intrauterine device.…”

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use

“…The significant reduction in overall menstrual bleeding with the LNG 52 mg IUS encouraged further studies which led to its approval for treatment of heavy menstrual bleeding (HMB) [4,5]. Much has been published about decrease in menstrual flow and amenorrhea in women using a LNG 52 mg IUS for HMB [6] but little about changes in women using the product primarily for contraception.…”

Comparative study on levonorgestrel intrauterine system and oral progestogen in women with heavy menstrual bleeding in terms of efficacy, user satisfaction and quality of life using MMAS score

“…5 Similar results were observed by Mewat et al and Kaunitz et al in their trials. 10,11 A total of 36 (90%) women in group I and 29 (72.5%) women in group II were found to be satisfied in our study (p=0.000). Romer et al reported the satisfaction level of 95% among patients using LNG IUS.…”