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
Verified date | October 2020 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trials Registry Team | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
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 |
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