Study to Evaluate Physician Awareness and Knowledge of Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Monotherapies in Europe: an Observational Post-Authorisation Joint Safety Study (Safe-CAM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  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:
  Observational survey

Study drug and medical condition

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

  Prostate cancer

  Antiandrogen therapy

Population studied

• Short description of the study population:
  A survey of physicians, including dermatologists, endocrinologists, gynaecologists, general practitioners, urologists, oncologists, and psychiatrists, involved in treating hypersexuality and reducing drive in sexual deviations, who have prescribed cyproterone acetate (CPA) in the past 12 months and work in office or hospital-based settings, is being conducted in France, Germany, Poland, Spain, and the Netherlands.; Inclusion criteria: ; 1. Licensed and practising dermatologist, endocrinologist, gynaecologist, general practitioners, urologist, oncologist (who treats prostate cancer), or psychiatrist involved in the treatment of hypersexuality/reduction of drive in sexual deviations ; 2. Prescribed CPA monotherapy to at least one patient in the past 12 months ; 3. Work in an office or hospital-based setting ; 4. Electronic acknowledgement of informed consent
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The primary objective of this study is to measure physician awareness and level of knowledge of the key safety information included in the revised summary of product characteristics (SmPC) and the Direct Healthcare Professional Communication (DHPC) for CPA monotherapy regarding the risk of meningioma.
• Outcomes:
  Percentage of physicians responding correctly to the knowledge questions. For more details, please visit www.clinicaltrials.gov and search using the study number 21490.
• Data analysis plan:
  All analyses will be descriptive in nature, and no hypothesis testing will be performed. The frequency distribution of responses to each individual question will be calculated.