Comparison of two levonorgestrel-releasing intrauterine systems for the treatment of heavy menstrual bleeding: a randomised, controlled, phase 3 trial.

PURPOSE

To evaluate the levonorgestrel-releasing intrauterine system Donasert (also known as Levosert) compared with the reference product Mirena for the alleviation of heavy menstrual bleeding (HMB).

MATERIALS AND METHODS

A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert or Mirena and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram.

RESULTS

Overall, 312 were randomised (158 to Donasert and 154 to Mirena). The mean (standard deviation) absolute change in MBL from baseline to 6 months in the per-protocol population ( = 300) was -130 (71.8) mL and -127 (67.3) mL in the Donasert and Mirena groups, respectively; non-inferiority of Donasert was confirmed (-value <0.0001). Successful treatment of HMB (MBL <80 mL) and a decrease to ≤50% of baseline MBL was achieved in 139/154 (90.3%) and 126/146 (86.3%) participants in the Donasert and Mirena groups, respectively and the between-treatment difference was non-significant. Most adverse events were mild in severity. Only two device expulsions occurred in the study and there were no uterine perforations.

CONCLUSIONS

Donasert has equivalent efficacy and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena.

TRIAL REGISTRATION NUMBER

348 (Clinical Trials Registry of the Ministry of Health of the Russian Federation, http://grls.rosminzdrav.ru/default.aspx).