title: A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India.
authors.forename: Rajmohan
authors.initials: R
authors.lastname: Gopimohan
authors.affiliation: Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India.
authors.forename: Amrutha
authors.initials: A
authors.lastname: Chandran
authors.affiliation: Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India.
authors.forename: Joyce
authors.initials: J
authors.lastname: Jacob
authors.affiliation: Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Bhaskar
authors.affiliation: Department of Community Medicine, Pushpagiri Institute of Medical Sciences and Research Centre, Tiruvalla, Kerala, India.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Aravindhakshan
authors.affiliation: Corporate R&D Centre, HLL Lifecare Ltd, Akkulam, Sreekariyam P.O., Thiruvananthapuram, Kerala, India. Electronic address: crdc@lifecarehll.com.
authors.forename: Abi S
authors.initials: AS
authors.lastname: Aprem
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000188:drug therapy* / Q000523:psychology; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: Abnormal uterine bleeding; Levonorgestrel intrauterine system; Menstrual blood loss