Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Cross-sectional survey, Qualitative study
• If ‘other’, further details on the scope of the study:
  Qualitative assessment

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G03F) PROGESTOGENS AND ESTROGENS IN COMBINATION

  PROGESTOGENS AND ESTROGENS IN COMBINATION

Population studied

• Short description of the study population:
  Prescribers and women of childbearing age (between 16 and 49 years of age)
• 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)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  1200

Study design details

• Main study objective:
  1. To consider the extent to which women and health professionals are aware of the risks of venous thromboembolism (VTE) in users of combined hormonal contraceptives (CHC)2. To document awareness, knowledge, attitudes and practices related to recommendations from regulatory authorities3. To understand how advice from regulators concerning CHC, and specifically how the risks of VTE are perceived
• Data analysis plan:
  Qualitative assessment of interviews and web survey results