Drug Utilization Study on the Prescribing Indications for CPA/EE in 5 European Countries

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G03HB01) cyproterone and estrogen

  cyproterone and estrogen
• Medical condition to be studied:
  Acne

Population studied

• Short description of the study population:
  Women who receives a Cyproterone acetate (CPA)/ethinylestradiol (EE) prescription during the study period.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The primary objective of the study is to characterize the prescribing behaviors for CPA/EE in 5 European countries, which includes the characterization of 1) prescribing indications for CPA/EE, 2) the use of CPA/EE in accordance with the updated label, 3) concomitant use of CPA/EE and combined hormonal contraceptives (CHCs), and 4) second line treatment of CPA/EE in the indication acne
• Outcomes:
  Proportion of off-label use per 100 prescriptions
• Data analysis plan:
  The study focuses on point estimates and 95% confidence intervals for the percentage of off-label use of CPA/EE. Reasons for prescription of CPA/EE will be investigated with respect to concomitant hormonal contraceptive use and androgen-sensitive diseases. Data analysis will be stratified by country and by specialization of the prescribing physician. Intra cluster (physician level) correlation of subjects will be considered by adjusting confidence limits. The precision of the point estimates will be high enough to assess the extent of off-label use of CPA/EE in the respective countries. Pattern of prescription behavior and disease characteristics will be described. A detailed statistical analysis plan will be developed by the investigator before study start. This plan will include methodological details and a set of mock tables for the presentation of results. Analyses of this cross sectional study will be limited to descriptive data.

Documents

Study results

Final Report 2016_05_23_final

France Addendum (only France) 12_21vf

Study report

EU-PAS_Abstract_Template_DUS_CPA_EE (003)