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OpenTrials
Completed

NCT Number: NCT02410031

Risk Minimisation Study for Diane-35 and Its Generics

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)

Drug

Cyproterone acetate 2mg/ethinylestradiol 35 μg

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • RTI Health Solutions

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2015
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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