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NCT04567589 Clinical Trial

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

Uterine Fibroids Clinical Trial

Official title:
A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04567589
Other study ID # CMO-EPI-WH-0618
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 30, 2020
Est. completion date February 28, 2021

Study information
Verified date October 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
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 Healthcare Professionals (HCPs).

Description:

Data will be collected via web-based data capture by HCPs submitting surveys. 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Status Withdrawn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 February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

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 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 Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure . HCP's recall of receiving and reading the HCP Letter and HCP Brochure . 18 - 24 months
Secondary Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card HCP's recall of distributing the Fibristal Patient Alert Card 18 - 24 months
Secondary Percentage of patients who recall counselling patients on information included in the Patient Alert Card HCP's recall of counselling patients on information included in the Patient Alert Card 18 - 24 months
Secondary Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions Composite score on the level of HCPs knowledge across all knowledge-related questions. 18 - 24 months
See also
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Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
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Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
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Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A
Terminated NCT00737282 - Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids Phase 3