LeiomyomaNCT02580578
A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids
An observational study of Leiomyoma, run by Allergan at 20 sites in Canada.
Trial summary
This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma
- How many people
- 1,500 participants
- Where
- 20 sitesCanada
- Study dates
- 31 Jul 2015to 31 Jan 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.
Who may be able to join
- -Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.
Who cannot join
- -Significant pelvic pathology not associated with uterine fibroids.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
Peter Lougheed Centre/University of Calgary
Calgary, Alberta, T2E 7W7
Urestky Edmonton Clinic
Edmonton, Alberta, T5T 1L6
Landau Fredericton Clinic
Fredericton, New Brunswick, E3B 6H5
IWK Healtch Centre
Halifax, Nova Scotia, B3K 6R8
Hamilton Health Sciences
Hamilton, Ontario, L8S 4K1
Centre Gynécologie et Maternité
LaSalle, Quebec, H8N 1T9
Minimally Invasive Gynecology Clinic
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3S 1Y9
Clinique de Gynécologie & Obstétrique Pierre Boucher
Montreal, Quebec, J4N 1C2
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9
CHU de Québec-Universite Laval
Québec, G1V 4G2
University of Saskatchewan
Regina, Saskatchewan, S4S 6X3
Complexe Medical Saint-Laurent
Saint-Laurent, Quebec, H4R 0B7
Strand Clinic
St. John's, Newfoundland and Labrador, L6G 0B5
St. Micheals Hospital
Toronto, Ontario, M5C 2T2
Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5
Sanders Vancouver Clinic
Vancouver, British Columbia, V5Z 4E1
Children's and Women's Health Centre of British Columbia - The University of British Columbia
Vancouver, British Columbia, V6H 3N1
Southern Health Centre
White Rock, British Columbia, V4B 5C9
South Windsor Women's Health
Windsor, Ontario, N9C 1X2
About this study
Official title: A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry
This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. The study will also assess the effectiveness of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and symptoms, and improvement in patient's quality of life.
- Conditions
- Leiomyoma
- Being tested
- No Intervention
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Female patients who are diagnosed and treated for symptoms associated with their uterine fibroids per routine clinical practice. No intervention is administered in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)
Measured: 24 Months
Ruta Menorrhagia (Bleeding) 15-Item Questionnaire
Measured: 24 Months
Number of Participants with Adverse Drug Reactions
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start31 Jul 2015
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmen Enciu, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580578
- Sponsor's protocol ID
- CMO-CAN-WH-0412
- Status last verified
- Feb 2020
- First submitted
- 19 Oct 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bougie O, Bedaiwy MA, Laberge P, Lebovic G, Leyland N, Atri M, Murji A; CAPTURE Steering Committee. Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry. CMAJ Open. 2020 Aug 12;8(3):E506-E513. doi: 10.9778/cmajo.20200004. Print 2020 Jul-Sep.
PubMed 32792350Bedaiwy MA, Janiszewski P, Singh SS; CAPTURE Steering Committee. A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study. JMIR Res Protoc. 2018 Nov 20;7(11):e10926. doi: 10.2196/10926.
PubMed 30459144
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry
- ClinicalTrials.gov ID
- NCT02580578
- Acronym / sponsor ID
- CMO-CAN-WH-0412
- Conditions
- Leiomyoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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 study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. The study will also assess the effectiveness of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and symptoms, and improvement in patient's quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionFemale patients who are diagnosed and treated for symptoms associated with their uterine fibroids per routine clinical practice. No intervention is administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.
Key inclusion criteria (1 listed)
- -Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.
Key exclusion criteria (1 listed)
- -Significant pelvic pathology not associated with uterine fibroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention is administered in this study. | Other | All Participants |
Primary outcome
Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)
Time frame: 24 Months
Ruta Menorrhagia (Bleeding) 15-Item Questionnaire
Time frame: 24 Months
Number of Participants with Adverse Drug Reactions
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 32792350Bougie O, Bedaiwy MA, Laberge P, Lebovic G, Leyland N, Atri M, Murji A; CAPTURE Steering Committee. Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry. CMAJ Open. 2020 Aug 12;8(3):E506-E513. doi: 10.9778/cmajo.20200004. Print 2020 Jul-Sep.
- Derived from this study: PubMed 30459144Bedaiwy MA, Janiszewski P, Singh SS; CAPTURE Steering Committee. A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study. JMIR Res Protoc. 2018 Nov 20;7(11):e10926. doi: 10.2196/10926.
Related trials for Leiomyoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
RecruitingObservational study
Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid
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.
Carmen Enciu study director
Allergan
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma, run by Allergan at 20 sites in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL) (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580578, which also lists 2 linked publications.
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 28 Feb 2020.