Risk Minimisation Study for Diane-35 and Its Generics

April 4, 2017 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

759

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians eligible to participate who have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey
Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
Cyproterone acetate 2mg/ethinylestradiol 35 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

RTI Health Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2015

Primary Completion (Actual)

March 4, 2016

Study Completion (Actual)

March 4, 2016

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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