A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding

Objective: To evaluate the efficacy and safety of a new variant of the levonorgestrel-intrauterine system (LNGIUS) Emily for the treatment of abnormal uterine bleeding (AUB). Methods: A prospective, multicenter, single-arm, phase 4 study was conducted at six centers in India between July 2012 and August 2013, Eligible women were aged 30-50 years, had completed their family, had AUB, and a pictorial bleeding assessment chart (PBAC) score of at least 100. After screening (visit 1) and insertion of the device (visit 2), participants were followed up at 1 week, 1 month, 3 months, and 6 months. The primary outcomes were menstrual blood loss (assessed by PBAC) and quality of life (assessed by the EQ-5D-3 L questionnaire). Results: Among 63 participants, 45 (71%) completed the study. Mean PBAC score decreased from 238.0 +/- 128.7 at screening to 13.1 +/- 19.2 at 6 months (P < 0.001). EQ-5D-3 L score increased from 79.0 +/- 14.1 at visit 2 to 86.3 +/- 9.0 at 6 months (P = 0.003). No serious adverse events related to the device were reported. Conclusion: Among women with AUB, use of the Emily LNG-IUS significantly reduces menstrual bleeding and improves quality of life. (C) 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.