Post Authorization Safety Study: Knowledge about safety precautions among physicians in Denmark prescribing CPA/EE products

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Post Authorisation Safety Study

Study drug and medical condition

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

  cyproterone and estrogen

Population studied

• Short description of the study population:
  Physicians in Denmark prescribing cyproterone and estrogen products.
• 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:
  0

Study design details

• Main study objective:
  DUS: To collect information about the indications physicians use for prescribing CPA/EE products in current clinical practice in Denmark.PASS: To collect information about physicians’ knowledge of contraindications and the key safety precautions to be observed when prescribing CPA/EE products in current clinical practice in Denmark.
• Outcomes:
  Does physicians use the correct indications for prescribing CPA/EE products in current clinical practice in Denmark.Are physicians’ knowledge of contraindications and key safety precautions correct, when prescribing CPA/EE products in current clinical practice in Denmark.
• Data analysis plan:
  Each questionnaire will be reviewed for completeness and for possible errors prior to data entry. A detailed review and analysis of responses to individual questions with summaries across logical groupings of response items will be made. Results will be stratified by logical variables, if relevant and possible. Descriptive statistics will be used to indicate how many percent of the doctors that gave correct replies to the yes or no questions (nominal scale). Confidence intervals will be calculated to describe the variation in the likely true value in the population of regular prescribers. Accounting for non-participants will be also be performed. Information in the report will be anonymous with regard to source.