Study Stopped
This study was cancelled before any data collection due to business reasons.
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
1 other identifier
observational
N/A
1 country
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 Healthcare Professionals (HCPs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedOctober 22, 2020
October 1, 2020
5 months
September 1, 2020
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of HCPs with correct responses to the knowledge level questions.
Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.
18 - 24 months
Secondary Outcomes (4)
Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure .
18 - 24 months
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card
18 - 24 months
Percentage of patients who recall counselling patients on information included in the Patient Alert Card
18 - 24 months
Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions
18 - 24 months
Eligibility Criteria
The survey will endeavor to collect 150 completed HCP surveys.
You may qualify if:
- HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.
- HCPs have provided permission to share their responses in aggregate to Health Canada.
You may not qualify if:
- HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
- HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Clinical Trials Registry Team
Irvine, California, 92622, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahunna Ukah
Allergan
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
September 30, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
October 22, 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.
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/.