Rajmohan Gopimohan1, Amrutha Chandran1, Joyce Jacob1, Sunil Bhaskar1, Rajeev Aravindhakshan2, Abi S Aprem3. 1. Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India. 2. Department of Community Medicine, Pushpagiri Institute of Medical Sciences and Research Centre, Tiruvalla, Kerala, India. 3. Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India. Electronic address: crdc@lifecarehll.com.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of a new variant of the levonorgestrel-intrauterine system (LNG-IUS)-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 30-50years, 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 1week, 1month, 3months, and 6months. The primary outcomes were menstrual blood loss (assessed by PBAC) and quality of life (assessed by the EQ-5D-3L 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 6months (P<0.001). EQ-5D-3L score increased from 79.0±14.1 at visit 2 to 86.3±9.0 at 6months (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. Clinical Trials Registry of India: CTRI/2012/07/002843.
OBJECTIVE: To evaluate the efficacy and safety of a new variant of the levonorgestrel-intrauterine system (LNG-IUS)-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 30-50years, 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 1week, 1month, 3months, and 6months. The primary outcomes were menstrual blood loss (assessed by PBAC) and quality of life (assessed by the EQ-5D-3L 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 6months (P<0.001). EQ-5D-3L score increased from 79.0±14.1 at visit 2 to 86.3±9.0 at 6months (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. Clinical Trials Registry of India: CTRI/2012/07/002843.