Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
Overview
- Phase
- Not Applicable
- Intervention
- Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
- Conditions
- Acne Vulgaris
- Sponsor
- Bayer
- Enrollment
- 759
- Primary Endpoint
- The knowledge of the physician concerning Diane-35
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.
Specifically, the following objectives will be addressed:
- Investigate whether physicians have received any educational material related to Diane-35 or its generics
- Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
- Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
- Contraindications relevant to thromboembolism
- Risk factors for thromboembolism
- Signs and symptoms of thromboembolism
Investigators
Eligibility Criteria
Inclusion Criteria
- •Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Exclusion Criteria
- Not provided
Arms & Interventions
Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey
Intervention: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
Outcomes
Primary Outcomes
The knowledge of the physician concerning Diane-35
Time Frame: Day1
The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist