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)

• ClinicalTrials.gov Identifier: NCT04925180
• Recruitment Status: Completed
• First Posted: June 14, 2021
• Last Update Posted: January 12, 2022
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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)

Study Design

• Study Type: Observational
• Actual 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)
• Actual Study Start Date: October 18, 2021
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Many Locations

Multiple Locations, France

Germany

Many Locations

Multiple Locations, Germany

Netherlands

Many Locations

Multiple Locations, Netherlands

Poland

Many Locations

Multiple Locations, Poland

Spain

Many Locations

Multiple Locations, Spain

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04925180
• Other Study ID Numbers: 21490
• First Posted: June 14, 2021
• Last Update Posted: January 12, 2022
• Last Verified: January 2022

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.

• 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:

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