Vaginal micronized progesterone versus the levonorgestrel-releasing intrauterine system for treatment of non-atypical endometrial hyperplasia: A randomized controlled trial.

Objective: To compare the efficiency of vaginal micronized progesterone (VMP) with the levonorgestrel-releasing intrauterine system (LNG-IUS) in patients with non-atypical endometrial hyperplasia. A validated Menorrhagia Impact Questionnaire (MIQ) was used to assess the quality of life before and after the procedure.

Methods: In this prospective trial, 144 women were randomly assigned to the VMP or LNG-IUS group. The primary endpoint was the regression rate of endometrial hyperplasia after 3 months of treatment. The protocol was approved by the institutional ethics committee and registered at ClinicalTrials.gov (NCT03992937).

Results: In all, 138 patients were analyzed. The regression rate was not significantly different between the groups (95.8% with LNG-IUS vs. 90.8% with VMP; P = 0.194). Differences between pre- and post-treatment MIQ scores were similar, except that better scores were obtained in the VMP group for the perception of the amount of blood loss (P = 0.035).

Conclusion: VMP is as effective as the LNG-IUS as a local treatment of endometrial hyperplasia without atypia.

Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03992937.