Trial Condition(s):

Acne vulgaris

Risk Minimisation Study for Diane-35 and Its Generics

Bayer Identifier:

17195

ClinicalTrials.gov Identifier:

NCT02410031

EudraCT Number:

Not Available

Study Completed

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
759
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Diane 35 (EE/CPA, BAY86-5264)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many Locations, Austria

Status
Completed
 

Trial Design