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NCT04567095 Clinical Trial

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

Uterine Fibroids Clinical Trial

Official title:
A Cross-sectional Study Among Patients in Canada to Assess Awareness and Knowledge of the Fibristal Patient Alert Card

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04567095
Other study ID # CMO-EPI-WH-0626
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 31, 2020
Est. completion date June 30, 2021

Study information
Verified date October 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Clinical Trials Registry Team Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card. 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.) 18 - 24 months
Secondary Percentages of patients that recall recieving and using the Fibristal Patient Alert Card Receipt and use of the Fibristal Patient Alert Card, 18 - 24 months
Secondary Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM Timing and frequency of liver testing conducted by the patients's HCP 18 - 24 months
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