title: A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.
abstract: 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.
  
  
  
  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.
  
  
  
  NCT01397097.
authors.affiliation: VL-Medi Clinical Research Center, Helsinki, Finland. Electronic address: dan.apter@vlmedi.fi.
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.affiliation: May Logan Centre, Bootle, United Kingdom.
authors.forename: Paula
authors.initials: P
authors.lastname: Briggs
authors.affiliation: Lääkäriasema Cantti Oy, Kuopio, Finland.
authors.forename: Marjo
authors.initials: M
authors.lastname: Tuppurainen
authors.affiliation: Bayer Pharma AG, Wuppertal, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Grunert
authors.affiliation: Bayer Oy, Espoo, Finland.
authors.forename: Eeva
authors.initials: E
authors.lastname: Lukkari-Lax
authors.affiliation: Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.
authors.forename: Sarah
authors.initials: S
authors.lastname: Rybowski
authors.affiliation: Division of Obstetrics and Gynecology, Department of Women's and Children's Health, Karolinska Institutet/Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Gemzell-Danielsson
mesh_terms: D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004343:Drug Implants; D005060:Europe; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008598:Menstruation / Q000187:drug effects; D017060:Patient Satisfaction; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D004343:Drug Implants; C044815:etonogestrel; D016912:Levonorgestrel; D017135:Desogestrel
keywords: LARC; LNG-IUS; contraception; discontinuation; etonogestrel implant