A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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ClinicalTrials.gov Identifier: NCT04567589
Recruitment Status :
(This study was cancelled before any data collection due to business reasons.)
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).
Condition or disease
Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.
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Ages Eligible for Study:
Child, Adult, Older Adult
The survey will endeavor to collect 150 completed HCP surveys.
HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.
HCPs have provided permission to share their responses in aggregate to Health Canada.
HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Clinical Study Report (CSR)
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type