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

Abstract

This study is the first to assess the low-dose levonorgestrel intrauterine system LNG-IUS 8 (average approximate release rate 8μg/24h over the first year and total content 13.5mg) specifically in females<18years of age and confirms the safety and efficacy of LNG-IUS 8 in an adolescent population.

Long-acting reversible contraception in adolescents: a systematic review and meta-analysis

“…There were a total of 27 points assigned in the following categories: reporting (10 points possible), external validity (3 points possible), bias (7 points possible), and confounding (7 points possible). Studies were grouped according to their score, with high scores indicating lower risk bias: excellent (25)(26)(27), good (19)(20)(21)(22)(23)(24), fair (14)(15)(16)(17)(18), and poor (<14).…”

“…After exclusions, 12 articles that met all criteria and were included for analysis. [15][16][17][18][19][20][21][22][23][24][25][26] Figure 1 shows the selection of included articles.…”

“…Among the included studies, 755 subjects used the subdermal implant and 4131 used the IUD. There were 8 studies that included the Cu-IUD, [15][16][17][18][20][21][22][23] 9 studies that included the LNG-IUD, [15][16][17][18][20][21][22][23]26 and 4 studies that included the ENG implant. 19,22,25,27 Many of the studies compared LARC methods.…”

“…Five studies were prospective cohort studies [19][20][21]26,27 and 6 studies were retrospective cohort studies. [15][16][17]21,23,25 Overall, approximately 34% of adolescents in the included studies were nulliparous.…”

“…Systematic Reviews ajog.org performed in Brazil, 19 and 1 study was a multinational study. 26 Randomized controlled trial Godfrey and colleagues 18 performed a pilot RCT that randomized 23 adolescents and young women between age 13-18 years to either Cu-IUD (n ¼ 11) or LNG-IUD (n ¼ 12). Subjects had an interval IUD placement or placement at least 7 weeks postpartum.…”