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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not applicable
研究组 & 干预措施
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).
干预措施: Cyproterone Acetate (Androcur, BAY94-8367) (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: Baseline
Percentage of physicians responding correctly to the knowledge question: The risk of meningioma increases with increasing cumulative doses of CPA
时间窗: Baseline
Percentage of physicians responding correctly to the knowledge question: CPA is contraindicated in patients with a meningioma or a history of meningioma
时间窗: 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
时间窗: Baseline
Percentage of physicians responding correctly to the knowledge question: Awareness of signs and symptoms of meningiomas
时间窗: Baseline
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
时间窗: Baseline
次要结局
未报告次要终点