Risk Minimisation Study for Diane-35 and Its Generics

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)

• Registration Number: NCT02410031
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Study Start: 2015-06-26
• Primary Completion: 2016-03-04
• Study Completion: 2016-03-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

Inclusion Criteria

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The knowledge of the physician concerning Diane-35	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