A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids

NCT ID: NCT02580578

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leiomyoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No Intervention

Intervention Type OTHER

No intervention is administered in this study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

No intervention is administered in this study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.

Exclusion Criteria

-Significant pelvic pathology not associated with uterine fibroids.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carmen Enciu

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peter Lougheed Centre/University of Calgary

Calgary, Alberta, Canada

Site Status

Urestky Edmonton Clinic

Edmonton, Alberta, Canada

Site Status

Sanders Vancouver Clinic

Vancouver, British Columbia, Canada

Site Status

Children's and Women's Health Centre of British Columbia - The University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Southern Health Centre

White Rock, British Columbia, Canada

Site Status

Landau Fredericton Clinic

Fredericton, New Brunswick, Canada

Site Status

Strand Clinic

St. John's, Newfoundland and Labrador, Canada

Site Status

IWK Healtch Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Minimally Invasive Gynecology Clinic

London, Ontario, Canada

Site Status

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

St. Micheals Hospital

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

South Windsor Women's Health

Windsor, Ontario, Canada

Site Status

Centre Gynécologie et Maternité

LaSalle, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Clinique de Gynécologie & Obstétrique Pierre Boucher

Montreal, Quebec, Canada

Site Status

Complexe Medical Saint-Laurent

Saint-Laurent, Quebec, Canada

Site Status

University of Saskatchewan

Regina, Saskatchewan, Canada

Site Status

CHU de Québec-Universite Laval

Québec, , Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32792350 (View on PubMed)

Bedaiwy 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.

Reference Type DERIVED
PMID: 30459144 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMO-CAN-WH-0412

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiofrequency Ablation of Uterine Fibroids
NCT00584207 TERMINATED EARLY_PHASE1