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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

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