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Risk Minimisation Study for Diane-35 and Its Generics

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02410031
Enrollment
759
Registered
2015-04-07
Start date
2015-06-26
Completion date
2016-03-04
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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

Interventions

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

Cyproterone acetate 2mg/ethinylestradiol 35 μg

Sponsors

RTI Health Solutions
CollaboratorOTHER
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The knowledge of the physician concerning Diane-35Day1The 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

Countries

Austria, Czechia, France, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026