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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02410031 |
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Date of registration:
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02/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Risk Minimisation Study for Diane-35 and Its Generics
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Scientific title:
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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 |
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Date of first enrolment:
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June 26, 2015 |
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Target sample size:
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759 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02410031 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Austria
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Czech Republic
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France
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Netherlands
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Spain
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
-Physicians eligible to participate will have recently prescribed (e.g., within previous 6
months) Diane-35 or its generics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acne Vulgaris
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Intervention(s)
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Drug: Cyproterone acetate 2mg/ethinylestradiol 35 µg (Diane-35)
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Primary Outcome(s)
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The knowledge of the physician concerning Diane-35
[Time Frame: Day1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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