Risk Minimisation Study for Diane-35 and Its Generics

• Status: Completed
• Trial end date: 2016-03-04
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: RTI Health Solutions
• Treatments: Cyproterone; Cyproterone Acetate; Cyproterone acetate, ethinyl estradiol drug combination; Ethinyl Estradiol

Criteria

Inclusion Criteria:

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