check_circleStudy Completed
Acne Vulgaris
Bayer Identifier:
17195
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Risk Minimisation Study for Diane-35 and Its Generics
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
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
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
759Trial Dates
June 2015 - March 2016Phase
N/ACould I Receive a placebo
NoProducts
Diane 35 (EE/CPA, BAY86-5264)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Spain | |
Completed | Many Locations, France | |
Completed | Many Locations, Netherlands | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Austria |
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' checklistdate_rangeTime Frame:Day1enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A