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

Withdrawn

• Conditions: Uterine Fibroids

• Registration Number: NCT04567095
• 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 Patients in Canada.

Detailed Description

Data will be collected via web-based data capture and paper surveys depending on patient preference. 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
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Study Start: 2020-10-31
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Patients who have received Fibristal within 6 months of completing the survey.
• Patients who have provided permission to share their responses in aggregate with Health Canada.
• Patients who have provided informed consent for their participation in the survey.

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Exclusion Criteria

• Patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
• Patients who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past year.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.	18 - 24 months	Correct responses to knowledge-related questions (i.e, potential of fibristal to cause liver injury, signs and symptoms of liver problems, and what to do in case of signs and symptoms of liver problems.)

Secondary Outcome Measures

Name	Time	Method
Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM	18 - 24 months	Timing and frequency of liver testing conducted by the patients's HCP
Percentages of patients that recall recieving and using the Fibristal Patient Alert Card	18 - 24 months	Receipt and use of the Fibristal Patient Alert Card,

Trial Locations

Locations (1)

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