A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada

Withdrawn

• Conditions: Uterine Fibroids

• Registration Number: NCT04567589
• Lead Sponsor: Allergan

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).

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 Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Not specified
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of HCPs with correct responses to the knowledge level questions.	18 - 24 months	Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.

Secondary Outcome Measures

Name	Time	Method
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card	18 - 24 months	HCP's recall of distributing the Fibristal Patient Alert Card
Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure .	18 - 24 months	HCP's recall of receiving and reading the HCP Letter and HCP Brochure .
Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions	18 - 24 months	Composite score on the level of HCPs knowledge across all knowledge-related questions.
Percentage of patients who recall counselling patients on information included in the Patient Alert Card	18 - 24 months	HCP's recall of counselling patients on information included in the Patient Alert Card

Trial Locations

Locations (1)

Clinical Trials Registry Team; 🇺🇸 Irvine, California, United States