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

NCT04567095 | Withdrawn

• 1 other identifier: CMO-EPI-WH-0626
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentages of patients that recall recieving and using 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

  18 - 24 months

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The survey will endeavor to collect 150 completed patient surveys

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Clinical Trials Registry Team

Irvine, California, 92622, United States

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ahunna Ukah

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 28, 2020
• Study Start: October 31, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)