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 identification

• EU PAS number:
  EUPAS41194
• Study ID:
  50248
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Poland

  Spain
• Study description:
  Androcur is a type of treatment called cyproterone acetate (CPA). Androcur and other CPA treatments work by blocking a group of male sex hormones called androgens in the body. It can be given to men and women to treat conditions that are caused by higher levels of androgens. CPAs, including androcur, are currently available as treatments for doctors to give to patients who have these types of conditions. But, in a study, researchers found that participants had a certain medical problem when they took CPAs for a long time. This medical problem was a tumor of the brain or spinal cord that is mostly not malignant and is called meningioma. This eventually led health authorities to change the instructions for how doctors should use CPAs to treat patients. This included what health conditions should be treated with CPAs, how long patients should receive them, and what dose of CPA should be given. In this study, the researchers want to learn more about how doctors are using CPAs to treat patients after the update to the instructions. To answer this research question, they will give to the doctors a web-based questionnaire asking about the advisability or necessity of the treatment (also called “indications of approved use”), the measures to be followed to reduce the risk and how much the doctors knew about the risk of meningioma. The researches will then analyze the answers to the questionnaire. The results will be the percentage of physicians with correct answers for each individual knowledge question from the questionnaire. The study will include information collected from a diverse sample of doctors during approximately 3 months. The doctors must have given CPAs as a treatment to at least 1 patient in the last 12 months. There are no required visits or tests in this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned: 18/02/2021

Actual: 18/02/2021

Study start date

Planned: 20/10/2021

Actual: 18/10/2021

Date of final study report

Planned: 01/07/2022

Actual: 05/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)