Reporting of clinical trial results

LEO Pharma considers it an ethical and scientific responsibility to report the results of our clinical trials.
LEO Pharma considers result reporting for clinical trials to be an ethical and scientific responsibility. By ensuring that all our clinical trial results are accessible, we minimise the risk for biased and selective reporting.
 
A fundamental component of LEO Pharma’s endeavours for increased clinical trial
transparency is to guarantee return of clinical trial results to the patients. Our trial participants are informed where and when the trial results will become available, and we express our sincere gratitude in writing for their valuable contributions.
 

Public data registries

The clinical trial results of LEO Pharma are reported according to applicable laws and regulations and international recommendations in:

• www.clinicaltrials.gov
• www.clinicaltrialsregister.eu
• various national registries
 
Reporting is performed after completion or termination of the clinical trial according to set timelines by the governing authority, and the results of the trial are reported regardless of outcome.
 
Starting September 2019*, we publish the results of all trials with products that are approved anywhere in the world on the global public registry clinicaltrials.gov.

Important information regarding LEO Pharma Clinical Trial Disclosure

This site contains information about clinical trials sponsored by LEO Pharma. Clinical trials sponsored by LEO Pharma means the studies conducted by LEO Pharma or, if relevant, studies conducted by a third party where LEO Pharma has acquired a medicinal product from this third party.

Access to the site requires that you acknowledge and accept the following:

  • The information on this website is provided solely to increase transparency of LEO Pharma clinical trials. It is not intended to promote any prescription, sale, or use, whether approved or off-label, of any medicinal product from LEO Pharma or from any other company.

  • The documents on this site have been prepared in accordance with applicable ICH guidelines upon completion of the respective clinical trials. Except edits necessary for the protection of commercially confidential information and those for the protection of personal data, the documents are in the same format as they were originally prepared for approvals from the regulatory authorities.

  • The documents provided on this site contain data and results regarding approved and non-approved uses, formulations or treatment regimens. As data and results from clinical trials are of a scientific nature, you cannot rely on this information as a recommendation or advice regarding the use/non-use of any products or treatment options.

  • The information is not intended to replace the advice of a healthcare professional. As a patient, you must always consult your doctor for further information and instructions.

  • The information is not intended to be used by physicians for making prescribing decisions. If you are a physician, you should always refer to the specific authority-approved labelling information approved for the product in the country or region of the patient.

  • The information on this part of the website is provided “as is” and LEO Pharma does not accept any liability for the accuracy, completeness or use of this information. LEO Pharma does not assume any obligation in connection with updating the documents and information available on this part of the site. Please read more in our Terms of Use.

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