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Risk Minimisation Study for Diane-35 and Its Generics

NCT02410031 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 759

Last updated 2017-04-05

No results posted yet for this study

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

Conditions

  • Acne Vulgaris

Interventions

DRUG

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

Cyproterone acetate 2mg/ethinylestradiol 35 μg

Sponsors & Collaborators

  • RTI Health Solutions

    collaborator OTHER

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2016-03-04
Completion
2016-03-04

Countries

  • Austria
  • Czechia
  • France
  • Netherlands
  • Spain

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410031 on ClinicalTrials.gov