EMA drug utilisation study of cyproterone-ethinylestradiol products

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

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

  ETHINYLESTRADIOL
• Medical condition to be studied:
  Contraception

Population studied

• Short description of the study population:
  Female patients receiving cyproterone/ethinylestradiol during 2002-2011.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  To study the drug utilisation of cyproterone/ethinylestradiol in Electronic Health Record databases from UK, France and Germany.
• Data analysis plan:
  Descriptive analyses only