Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CYPROTERONE ACETATE
• Medical condition to be studied:
  Acne

Population studied

• Short description of the study population:
  Physicians who have experience with Diane-35 or its generic versions in five European countries: Austria, the Czech Republic, the Netherlands, Spain, and France.; Physicians who met all of the following eligibility criteria were included:; 1. Licensed and practicing dermatologist, gynaecologist, or general practitioner; 2. Prescribed Diane-35 or a generic version to at least one patient in the past 6 months
• Age groups:
  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:
  759

Study design details

• Main study objective:
  The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers’ Checklist
• Outcomes:
  The knowledge of the physician concerning Diane-35
• Data analysis plan:
  Analyses will include detailed review of responses to individual questions and potential summary measures across logical groupings of response items. Results will be stratified by country and other logical variables, such as physician specialty and experience with Diane-35 or its generics. A detailed analysis plan describing methods of analysis and presentation and including table shells will be developed prior to starting data collection