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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Uterine Fibroids

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92622
      • Clinical Trials Registry Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The survey will endeavor to collect 150 completed patient surveys

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Ahunna Ukah, Allergan

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: CMO-EPI-WH-0626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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/.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No