title: A multicentre, open-label, randomised phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral contraception in young women of reproductive age.
abstract: OBJECTIVE
  To compare user satisfaction and adverse events (AEs) with a levonorgestrel intrauterine system (LNG-IUS 8; average levonorgestrel release rate approximately 8 μg/24 h over the first year [total content 13.5 mg]) and a 30 μg ethinyl estradiol/3 mg drospirenone (EE/DRSP) combined oral contraceptive (COC) in a population of young women.
  
  
  METHODS
  Nulliparous and parous women (aged 18-29 years) with regular menstrual cycles (21-35 days) were randomised to LNG-IUS 8 or EE/DRSP for 18 months. The primary endpoint was the overall user satisfaction rate at month 18/end of study visit.
  
  
  RESULTS
  Overall, 279 women were randomised to LNG-IUS 8 with attempted placement and 281 women were randomised to EE/DRSP and took ≥1 pill; the mean age was 23.7 and 23.9 years, and 77.4% and 73.3% were nulliparous, respectively. At month 18/end of study, 82.1% and 81.9% of women, respectively, reported being 'very satisfied' or 'satisfied' with their treatment; however, significantly more LNG-IUS 8 users reported a preference to continue their treatment post-study (66.2% vs 48.8%; p = 0.0001). There were two pregnancies (one ectopic pregnancy, one spontaneous abortion) reported in the LNG-IUS 8 group and six (three live births, two spontaneous abortions, one induced abortion) in the EE/DRSP group.
  
  
  CONCLUSIONS
  LNG-IUS 8 and EE/DRSP were associated with similarly high user satisfaction rates. However, LNG-IUS 8 users were significantly more likely to prefer to continue their contraceptive method post-study, indicating that a levonorgestrel intrauterine system is an appealing contraceptive option for young women.
authors: a Department of Obstetrics and Gynecology , Boston University School of Medicine , Boston , MA , USA ;
authors: Lynn
authors: L
authors: Borgatta
authors: b Department of Gynecological Endocrinology , University Hospital Hamburg-Eppendorf , Hamburg , Germany ;
authors: Kai J
authors: KJ
authors: Buhling
authors: c Bayer HealthCare Pharmaceuticals , Whippany , NJ , USA ;
authors: Sarah
authors: S
authors: Rybowski
authors: d Bayer Pharma AG , Berlin , Germany.
authors: Katrin
authors: K
authors: Roth
authors: c Bayer HealthCare Pharmaceuticals , Whippany , NJ , USA ;
authors: Kimberly
authors: K
authors: Rosen
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000627:therapeutic use*; D001317:Austria; D001530:Belgium; D003271:Contraceptive Agents, Female / Q000627:therapeutic use; D003277:Contraceptives, Oral, Combined / Q000627:therapeutic use*; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000627:therapeutic use*; D017060:Patient Satisfaction; D014481:United States; D055815:Young Adult
chemical_list: D000736:Androstenes; D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel
keywords: Combined oral contraception; LARC; LNG-IUS; intrauterine contraception; intrauterine system; long-acting reversible contraception