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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567589
Recruitment Status : Withdrawn (This study was cancelled before any data collection due to business reasons.)
First Posted : September 28, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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
Uterine Fibroids

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of HCPs with correct responses to the knowledge level questions. [ Time Frame: 18 - 24 months ]
    Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.


Secondary Outcome Measures :
  1. Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure . [ Time Frame: 18 - 24 months ]
    HCP's recall of receiving and reading the HCP Letter and HCP Brochure .

  2. Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card [ Time Frame: 18 - 24 months ]
    HCP's recall of distributing the Fibristal Patient Alert Card

  3. Percentage of patients who recall counselling patients on information included in the Patient Alert Card [ Time Frame: 18 - 24 months ]
    HCP's recall of counselling patients on information included in the Patient Alert Card

  4. Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions [ Time Frame: 18 - 24 months ]
    Composite score on the level of HCPs knowledge across all knowledge-related questions.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
The survey will endeavor to collect 150 completed HCP surveys.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567589


Locations
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United States, California
Clinical Trials Registry Team
Irvine, California, United States, 92622
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Ahunna Ukah Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04567589    
Other Study ID Numbers: CMO-EPI-WH-0618
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms