Comparison of Levonorgestrel-Releasing Intrauterine System, Medroxyprogesterone and Norethisterone for Treatment of Endometrial Hyperplasia without Atypia: A Randomized Clinical Trial

Objective:to assess the efficacy, acceptability and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) compared to oral Medroxyprogesterone (MPA) and Norethisterone (NETA) for treatment of endometrial hyperplasia (EH) without atypia in perimenopausal women. Methods:This randomized clinical study included 150 perimenopausal women with endometrial hyperplasia (EH) without atypia who were randomly assigned into three groups; 50 patients received 15 mg Medroxyprogesterone acetate (MPA), 50 patients received 15 mg Norethisterone acetate (NETA) and 50 patients in whom levonorgestrel-releasing intrauterine system (LNG-IUS) was inserted. Endometrial sampling was repeated after 6 months of therapy. Primary outcome was regression of EH while secondary outcomes included side effects, patient acceptability and cost of treatment over six months. Results:There was no significant difference between the three groups regarding regression of EH (p<0.05). The LNG-IUS has the highest cost and acceptability (p<0.001). There was a significant higher women suffering from nausea in NETA group (p<0.05), acne in MPA group(P<0.05) and vaginal discharge in LNG-IUS group(p<0.05). Conclusion:In low-income and developing countries where the LNG-IUS is non affordable or unavailable, the use of norethisterone seems a viable cost-effective therapy in patients with endometrial hyperplasia without atypia.