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

GEZER Ş., Kole E., Aksoy L.

INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS, 2023 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Publication Date: 2023
  • Doi Number: 10.1002/ijgo.14632
  • Journal Name: INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, CAB Abstracts, CINAHL, EMBASE, Gender Studies Database, MEDLINE, Public Affairs Index
  • Keywords: levonorgestrel-releasing intrauterine system, non-atypical endometrial hyperplasia, vaginal micronized progesterone, Bayer, EFFICACY, MENORRHAGIA, PROGESTINS, THERAPY, DEVICE, IMPACT
  • Kocaeli University Affiliated: Yes

Abstract

ObjectiveTo 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. MethodsIn 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 (NCT03992937). ResultsIn 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). ConclusionVMP is as effective as the LNG-IUS as a local treatment of endometrial hyperplasia without atypia. Trial registration.