Uterine FibroidsNCT04567589
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
An observational study of Uterine Fibroids, run by Allergan at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uterine Fibroids
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: The survey will endeavor to collect 150 completed HCP surveys.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Registry Team
Irvine, California, 92622
About this study
Official title: A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
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).
Read the detailed 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.
- Conditions
- Uterine Fibroids
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 - 24 months
Secondary outcomes (4)
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 .
Measured: 18 - 24 months
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card
HCP's recall of distributing the Fibristal Patient Alert Card
Measured: 18 - 24 months
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
Measured: 18 - 24 months
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.
Measured: 18 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start30 Sep 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Why it stopped: This study was cancelled before any data collection due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahunna Ukah, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567589
- Sponsor's protocol ID
- CMO-EPI-WH-0618
- Status last verified
- Oct 2020
- First submitted
- 1 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
- ClinicalTrials.gov ID
- NCT04567589
- Acronym / sponsor ID
- CMO-EPI-WH-0618
- Conditions
- Uterine Fibroids
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was cancelled before any data collection due to business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- The survey will endeavor to collect 150 completed HCP surveys.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of HCPs with correct responses to the knowledge level questions.
Time frame: 18 - 24 months
Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.
4 secondary outcomes
Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure .
Time frame: 18 - 24 months
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card
Time frame: 18 - 24 months
Percentage of patients who recall counselling patients on information included in the Patient Alert Card
Time frame: 18 - 24 months
Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions
Time frame: 18 - 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahunna Ukah study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of HCPs with correct responses to the knowledge level questions. (time frame: 18 - 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.