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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04925180
Recruitment Status : Not yet recruiting
First Posted : June 14, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment
Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea Hypersexuality in Men Sexual Deviations in Men Prostate Cancer Drug: Cyproterone Acetate (Androcur, BAY94-8367)

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: 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)
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Physicians
Physicians who have recently prescribed (e.g., within previous 12 months) CPA monotherapy will be invited to complete a brief web-based questionnaire regarding their knowledge of the revised summary of product characteristics (SmPC) and the direct healthcare professional communication (DHPC).
Drug: Cyproterone Acetate (Androcur, BAY94-8367)
As prescribed by the treating physician




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline ]
  2. 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 [ Time Frame: Baseline ]
  3. 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 [ Time Frame: Baseline ]
  4. 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 [ Time Frame: Baseline ]
  5. Percentage of physicians responding correctly to the knowledge question: The risk of meningioma increases with increasing cumulative doses of CPA [ Time Frame: Baseline ]
  6. Percentage of physicians responding correctly to the knowledge question: CPA is contraindicated in patients with a meningioma or a history of meningioma [ Time Frame: Baseline ]
  7. 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 [ Time Frame: Baseline ]
  8. Percentage of physicians responding correctly to the knowledge question: Awareness of signs and symptoms of meningiomas [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Physicians eligible to participate will include dermatologists, endocrinologists, gynaecologists, general practitioners, urologists, oncologists (who treat prostate cancer), and psychiatrists involved in the treatment of hypersexuality/reduction of drive in sexual deviations who have prescribed CPA in the past 12 months and work in an office or hospital-based setting.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925180


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04925180    
Other Study ID Numbers: 21490
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Cyproterone acetate monotherapies
Effectiveness of risk minimization measures
Survey
Additional relevant MeSH terms:
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Alopecia
Hirsutism
Virilism
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Cyproterone Acetate
Cyproterone
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents