European Active Surveillance Study of LCS12 (EURAS-LCS12)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEVONORGESTREL
• Medical condition to be studied:
  Contraception

  Pelvic inflammatory disease

  Uterine perforation

  Ectopic pregnancy

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  83000

Study design details

• Main study objective:
  The main objective of this study is to assess the effectiveness and safety of LCS-12 in real life in new users as compared to Mirena and compared to copper IUDs.
• Outcomes:
  Yes, the primary clinical outcome of interest for the short- and long-term follow-up is: - Unintended pregnancy, Yes, secondary clinical outcomes of interest are - Ectopic pregnancy, - Pelvic inflammatory disease (PID) - Uterine perforations - Unintended pregnancies in users of Kyleena compared with users of Mirena and with users of copper IUDs
• Data analysis plan:
  Based on the similarities between LCS12 and Mirena, the a priori assumption is that use of LCS12 is not associated with an increased risk of unintended pregnancy compared to Mirena. Furthermore, it is expected that the risk is lower or equal to copper IUDs. A non-inferiority design was chosen to investigate contraceptive failure rate of LCS12. The primary analysis will be based on the comparison of the upper confidence limit for the point estimate of the contraceptive failure hazard ratio with the predefined non-inferiority limit. Multivariate techniques such as Cox regression will be used to take into consideration the influence of confounding. A more sophisticated analysis method (i.e. regression analyses based on propensity scores) will also be applied. Similar analyses are applied for the comparison between Kyleena, Mirena and copper IUDs.