EURopean Active Surveillance study - Comparing Regimens of Administration in combined hormonal contraception (EURAS - CORA)

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Name of medicine, other:
  Lisvy
• Medical condition to be studied:
  Deep vein thrombosis

  Pulmonary embolism

  Arterial thrombosis

  Skin reaction

  Pregnancy

Population studied

• Short description of the study population:
  Lisvy (FC Patch Low users) and users of COCLNG (including adolescents).; All starters and restarters (see above) of FC Patch Low or COCLNG who were willing to participate in the study were eligible for enrollment into the study.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  101000

Study design details

• Main study objective:
  To characterise and compare the risks of short- and long-term use of FC Patch Low with levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population that is representative of the actual users of the individual preparations. This includes an estimate of the absolute risk of rare serious adverse outcomes (e.g. venous thromboembolism, arterial thromboembolism).
• Outcomes:
  The main clinical outcomes of interest for short- and long-term follow-up are venous thromboembolisms (VTEs), specifically 1. Deep Venous Thrombosis of the lower extremities 2. Pulmonary Embolism. For FC Patch Low and LNG-COC users, describe, measure and compare 1. All VTE 2. Arterial thromboembolism incidence rate (IR) 3. All cancers IR 4. Application site reactions IR 5. Effect on short-/long-term fertility 6. Drug utilisations patterns and baseline risks for clinical outcomes 7. Pregnancy outcomes
• Data analysis plan:
  Sample size considerations are based on the expected VTE incidence of COC-LNG (10 VTE per 10,000 woman years as requested by CHMP). It is expected that FC Patch Low is associated with a VTE risk that is not higher than with COC-LNG. A non-inferiority approach will be used to test hypotheses. Crude and adjusted hazard ratios will be calculated, with stratification of women into user categories (first-ever user, re-starter). The final decision on confounding variables will be made by the Safety Monitoring and Advisory Council. Similar analyses will be performed for all VTE, arterial thromboembolism (which includes acute myocardial infarction and cerebrovascular accidents), other secondary variables and other serious adverse events. A detailed analysis plan will be developed by the Principal Investigator during the first year after study start. The final analysis plan will be approved by the Safety and Monitoring Advisory Council before the first interim analysis of follow-up data.

Documents

Study results

ECORA_SynopsisOfStudyStatus_EUPAS_20190522