Risk Minimisation Study for Diane-35 and Its Generics

Acne Vulgaris Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410031
• Other study ID #: 17195
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: April 4, 2017
• Start date: June 26, 2015
• Est. completion date: March 4, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: March 4, 2016
• Est. primary completion date: March 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	RTI Health Solutions

Countries where clinical trial is conducted

Austria,  Czech Republic,  France,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day1

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.