A retrospective longitudinal cohort study assessing the safety of Seasonique® use: A post-marketing authorization safety study (PASS) to assess the risk of venous thromboembolic events (VTE) in women exposed to Seasonique®

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEVONORGESTREL

  ETHINYLESTRADIOL

Population studied

• Short description of the study population:
  Women who have a record of at least one prescription dispensed for SEASONIQUE or 28-day cycle COCLNG (comparator) during the study period were included.; ; Patients were included in the study only if they meet all of the following criteria:; • Have a record of at least one prescription dispensed for SEASONIQUE or 28-day cycle COCLNG during the study period; • At least 12 months of continuous membership enrolment prior to first COC prescription
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  To assess the safety of Seasonique® use during standard clinical practice
• Outcomes:
  To evaluate the incidence rate of VTE in women exposed to Seasonique®, To evaluate the incidence rates of other CV events and gynaecological outcomes
• Data analysis plan:
  Risk will be estimated using Cox proportional hazards models, with adjustment for covariates.