A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant
The levonorgestrel intrauterine system total content 13.5 mg (average, w8 mg/24 hours during the first year) was associated with a significantly lower 12- month discontinuation rate than the etonogestrel subdermal implant, mainly because etonogestrel implant users more frequently discontinued due to increased bleeding.
Dan Apter, M.D., Ph.D., Paula Briggs, M.B.Ch.B., Marjo Tuppurainen, M.D., Julia Grunert, M.Sc., Eeva Lukkari-Lax, M.D., Ph.D., Sarah Rybowski, M.B.B.S., Kristina Gemzell-Danielsson, M.D., Ph.D.
To compare the levonorgestrel intrauterine system (LNG-IUS 8), which has an average levonorgestrel release rate of ∼8 μg/24 hours during the first year (total levonorgestrel content 13.5 mg; Jaydess/Skyla), with the etonogestrel (ENG) subdermal implant (total content, 68 mg) with regard to the 12-month discontinuation rate (primary outcome).
Randomized, open-label, phase III study.
Thirty-eight centers in six European countries.
Study population of 766 healthy nulliparous and parous women aged 18–35 years.
The LNG-IUS 8 or the ENG implant.
Main Outcome Measure(s)
Discontinuation rate, by treatment group, at Month 12.
The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The −7.2% difference was statistically significant (95% confidence interval −13.2%, −1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were “very/somewhat satisfied” with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%).
The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being “very/somewhat satisfied” with their bleeding pattern, and reported a preference to continue using their study treatment after the study.
Clinical Trial Registration Number
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