Trial Condition(s):

Signs of androgenisation in women, e.g. hirsutism, androgenetic alopecia, acne and seborrhea, Hypersexuality in men, Sexual deviations in men, Prostate Cancer

A study to learn about the awareness and knowledge that doctors have about the safety and safe use information for Androcur and other Cyproterone acetate treatments in Europe (Safe-CAM)

Bayer Identifier:

21490

ClinicalTrials.gov Identifier:

NCT04925180

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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
- Prescribed CPA monotherapy to at least one patient in the past 12 months
- Work in an office or hospital-based setting
- Electronic acknowledgement of informed consent
Exclusion Criteria
- Not applicable

Trial Summary

Enrollment Goal
600
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Androcur (Cyproterone Acetate, BAY94-8367)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, France

Status
Completed
 
Locations

Many Locations

Many Locations, Germany

Status
Completed
 
Locations

Many Locations

Many Locations, Netherlands

Status
Completed
 
Locations

Many Locations

Many Locations, Poland

Status
Completed
 
Locations

Many Locations

Many Locations, Spain

Status
Completed
 
Locations

Many Locations

Many Locations, Belgium

Status
Completed
 

Trial Design