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.