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A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding
Author(s) -
Gopimohan Rajmohan,
Chandran Amrutha,
Jacob Joyce,
Bhaskar Sunil,
Aravindhakshan Rajeev,
Aprem Abi S.
Publication year - 2015
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2014.11.023
Subject(s) - medicine , levonorgestrel , uterine bleeding , gynecology , clinical efficacy , obstetrics , clinical research , intrauterine device , metrorrhagia , family planning , population , research methodology , environmental health
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 30–50 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. Clinical Trials Registry of India: CTRI/2012/07/002843