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- W1972988166 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 30–50 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" @default.
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- W1972988166 date "2015-02-08" @default.
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- W1972988166 title "A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding" @default.
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- W1972988166 doi "https://doi.org/10.1016/j.ijgo.2014.11.023" @default.
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