Clinical trial · Observational
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
NCT04567095CI-TRIAL-00047886withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was cancelled before any data collection due to business reasons.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.
- timeFrame
- 18 - 24 months
- description
- 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 outcomes (2)
- measure
- Percentages of patients that recall recieving and using the Fibristal Patient Alert Card
- timeFrame
- 18 - 24 months
- description
- Receipt and use of the Fibristal Patient Alert Card,
- measure
- Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM
- timeFrame
- 18 - 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.