check_circleStudy Completed

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

Bayer Identifier:

21490

ClinicalTrials.gov Identifier:

NCT04925180

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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
  • - Not applicable

Trial summary

Enrollment Goal
600
Trial Dates
October 2021 - December 2021
Phase
N/A
Could I Receive a placebo
No
Products
Androcur (Cyproterone Acetate, BAY94-8367)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, France
Completed
Many LocationsMany Locations, Germany
Completed
Many LocationsMany Locations, Netherlands
Completed
Many LocationsMany Locations, Poland
Completed
Many LocationsMany Locations, Spain
Completed
Many LocationsMany Locations, Belgium

Primary Outcome

  • Percentage of physicians responding correctly to the knowledge question: The occurrence of meningiomas (single and multiple) in association with CPA monotherapy doses ≥ 25 mg/day
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: Restriction of use of CPA monotherapy 10 mg/50 mg in women when no results have been achieved at lower dose CPA-containing products or with other treatment options
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: Restriction of use of high-dose CPA in men with sexual deviations when other interventions are not appropriate
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: After clinical improvement with CPA monotherapy is achieved, treatment should be maintained with the lowest possible dose
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: The risk of meningioma increases with increasing cumulative doses of CPA
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: CPA is contraindicated in patients with a meningioma or a history of meningioma
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: If a patient treated with CPA monotherapy is diagnosed with meningioma, treatment with all cyproterone-containing products must be permanently stopped
    date_rangeTime Frame:
    Baseline
  • Percentage of physicians responding correctly to the knowledge question: Awareness of signs and symptoms of meningiomas
    date_rangeTime Frame:
    Baseline

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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