Trial Condition(s):
Acne vulgaris
Risk Minimisation Study for Diane-35 and Its Generics
Bayer Identifier:
17195
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
Inclusion Criteria
: -Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Czech Republic | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The knowledge of the physician concerning Diane-35The 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' checklistTimeframe: Day1
Additional Information
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