title: 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: To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5mg (average approximate release rate 8μg/24h over the first year; LNG-IUS 8; Jaydess®) in adolescents.
  
  
  
  In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17years) received LNG-IUS 8 for 12months. 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 12months, and Pearl Index.
  
  
  
  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 12months; 13.8% of participants discontinued owing to TEAEs.
  
  
  
  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 12months demonstrate that LNG-IUS 8 is a highly acceptable contraceptive method among adolescents.
  
  
  
  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.
authors.affiliation: Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. Electronic address: kristina.gemzell@ki.se.
authors.forename: Kristina
authors.initials: K
authors.lastname: Gemzell-Danielsson
authors.affiliation: University Hospital Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Kai J
authors.initials: KJ
authors.lastname: Buhling
authors.affiliation: Gynaecological Centre Dermout & Albicher, Alkmaar, The Netherlands.
authors.forename: Sylvia M
authors.initials: SM
authors.lastname: Dermout
authors.affiliation: Bayer Oy, Espoo, Finland.
authors.forename: Eeva
authors.initials: E
authors.lastname: Lukkari-Lax
authors.affiliation: Bayer HealthCare Pharmaceuticals, Newbury, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Montegriffo
authors.affiliation: VL-Medi Clinical Research Center, Väestöliitto, Helsinki, Finland.
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
mesh_terms: D000293:Adolescent; D002648:Child; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D020878:Device Removal / Q000706:statistics & numerical data; D005060:Europe; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D010298:Parity; D017060:Patient Satisfaction; D000292:Pelvic Inflammatory Disease / Q000209:etiology; D011247:Pregnancy; D011271:Pregnancy, Ectopic / Q000209:etiology; D049168:Pregnancy, Unplanned; D014595:Uterine Perforation / Q000209:etiology
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: Adolescent; Contraception; Intrauterine contraception; LNG-IUS; Nulliparous