Risk Minimisation Study for Diane-35 and Its Generics

Bayer

Status: Completed

Conditions: Acne Vulgaris

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02410031

17195

Details and patient eligibility

About

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

Enrollment: 759 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

759 participants in 1 patient group

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

Description:

Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey

Treatment:

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