check_circleStudy Completed

Acne Vulgaris

Bayer Identifier:

17195

ClinicalTrials.gov Identifier:

NCT02410031

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • -Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics

Trial summary

Enrollment Goal
759
Trial Dates
June 2015 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Diane 35 (EE/CPA, BAY86-5264)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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-35
    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
    date_rangeTime Frame:
    Day1
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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