Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia

Abstract

Objective To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrel-releasing intrauterine system for menorrhagia. Methods Sixty-three women with menorrhagia but without uterine enlargement, endometrial hyperplasia with atypia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial. An intrauterine system releasing 20 μg/day of levonorgestrel (LNG-IUS; Mirena, Shering, Finland) was inserted in the postmenstrual phase. Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Hemoglobin levels and endometrial thickness were evaluated at baseline and at 12 months. Treatment continuation and hysterectomy rates were noted as well as side effects. Results The device was expelled spontaneously in 6 patients (9.52%) and removed prematurely in 9 patients (14.3%); 3 patients (4.8%) were lost to follow-up; and 45 patients (71.4%) continued with the LNG-IUS. Menorrhagia was cured in 35 (77.7%) of these 45 patients at 3 months and in all patients at 36 months. There was a significant decrease in the mean number of bleeding days ( P = 0.01) and PBAC score ( P = 0.00) at 1 month, and the decrease continued with treatment duration. The subjective blood loss reduction was considerable as well, and at 12 months the mean ± SD rise in hemoglobin concentration was 1.06 ± 1.7 g/dL ( P = 0.000). Endometrial thickness was decreased by 3.4 ± 3.53 mm ( P = 0.0001) at 12 months. The most common side effect was intermenstrual spotting during the first 6 months, and 18 patients (28.57%) developed amenorrhea. Conclusion Using the LNG-IUS is an effective and well-accepted option overall for the medical management of menorrhagia.