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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04567095

Enrollment

Registered

2020-09-28

Start date

2020-10-31

Completion date

2021-06-30

Last updated

2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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,
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

Countries

United States

Outcome results