A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5 mg) in postmenarcheal adolescents

Objective: To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5 mg (average approximate release rate 8 mu g/24 h over the first year; LNG-IUS 8; Jaydess (R)) in adolescents. Study design: In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17 years) received LNG-IUS 8 for 12 months. The primary outcome was the incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included: serious TEAEs, adverse events of special interest, overall user satisfaction, discontinuation rate at 12 months, and Pearl Index. Results: LNG-IUS 8 placement was successful in 303/304 participants (99.7%). Overall, 82.6% of participants reported TEAEs, and serious TEAEs and serious study drug-related TEAEs were reported by 7.6% and 1.0% of participants, respectively. No cases of pelvic inflammatory disease, ectopic pregnancy, or uterine perforation were reported. No pregnancies were reported during the 12-month study. At Month 12/study end, the overall user satisfaction rate was 83.9%. Overall, 51 participants (16.8%) prematurely discontinued the study before 12 months; 13.8% of participants discontinued owing to TEAEs. Conclusions: No new or unexpected safety events were associated with the low-dose LNG-IUS 8. The safety profile of LNG-IUS 8 in adolescents was consistent with that previously reported in adults. The high overall user-satisfaction rate at study end and the low discontinuation rate over 12 months demonstrate that LNG-IUS 8 is a highly acceptable contraceptive method among adolescents. (C) 2016 The Authors. Published by Elsevier Inc.