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

NCT04925180 | Completed

• 1 other identifier: 21490
• Study Type: observational
• Target: 600
• Locations: 5 countries
• Sites: 5

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.

Conditions

Signs of Androgenisation in Women, e.g. Hirsutism, Androgenetic Alopecia, Acne and Seborrhea; Hypersexuality in Men; Sexual Deviations in Men; Prostate Cancer

Keywords

Cyproterone acetate monotherapies; Effectiveness of risk minimization measures; Survey

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  Baseline

• Percentage of physicians responding correctly to the knowledge question: The risk of meningioma increases with increasing cumulative doses of CPA

  Baseline

• Percentage of physicians responding correctly to the knowledge question: CPA is contraindicated in patients with a meningioma or a history of meningioma

  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

  Baseline

• Percentage of physicians responding correctly to the knowledge question: Awareness of signs and symptoms of meningiomas

  Baseline

Study Arms (1)

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)

Interventions

Cyproterone Acetate (Androcur, BAY94-8367) DRUG

As prescribed by the treating physician

Physicians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Many Locations

Multiple Locations, France

Location

Many Locations

Multiple Locations, Germany

Location

Many Locations

Multiple Locations, Netherlands

Location

Many Locations

Multiple Locations, Poland

Location

Many Locations

Multiple Locations, Spain

Location

MeSH Terms

Conditions

Alopecia; Acne Vulgaris; Dermatitis, Seborrheic; Prostatic Neoplasms

Interventions

Cyproterone Acetate

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Sebaceous Gland Diseases; Dermatitis; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 14, 2021
• Study Start: October 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); PL (1); ES (1); NL (1); FR (1)