NCT02580578

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

October 19, 2015

Last Update Submit

February 26, 2020

Conditions

Leiomyoma

Outcome Measures

Primary Outcomes (3)

  • Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)

    24 Months

  • Ruta Menorrhagia (Bleeding) 15-Item Questionnaire

    24 Months

  • Number of Participants with Adverse Drug Reactions

    24 Months

Study Arms (1)

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.

Other: No Intervention

Interventions

No InterventionOTHER

No intervention is administered in this study.

All Participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.

You may qualify if:

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

You may not qualify if:

  • Significant pelvic pathology not associated with uterine fibroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Peter Lougheed Centre/University of Calgary

Calgary, Alberta, T2E 7W7, Canada

Location

Urestky Edmonton Clinic

Edmonton, Alberta, T5T 1L6, Canada

Location

Sanders Vancouver Clinic

Vancouver, British Columbia, V5Z 4E1, Canada

Location

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

Vancouver, British Columbia, V6H 3N1, Canada

Location

Southern Health Centre

White Rock, British Columbia, V4B 5C9, Canada

Location

Landau Fredericton Clinic

Fredericton, New Brunswick, E3B 6H5, Canada

Location

Strand Clinic

St. John's, Newfoundland and Labrador, L6G 0B5, Canada

Location

IWK Healtch Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8S 4K1, Canada

Location

Minimally Invasive Gynecology Clinic

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

Location

St. Micheals Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

South Windsor Women's Health

Windsor, Ontario, N9C 1X2, Canada

Location

Centre Gynécologie et Maternité

LaSalle, Quebec, H8N 1T9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

Clinique de Gynécologie & Obstétrique Pierre Boucher

Montreal, Quebec, J4N 1C2, Canada

Location

Complexe Medical Saint-Laurent

Saint-Laurent, Quebec, H4R 0B7, Canada

Location

University of Saskatchewan

Regina, Saskatchewan, S4S 6X3, Canada

Location

CHU de Québec-Universite Laval

Québec, G1V 4G2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 32792350DERIVED

  • 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.

    PMID: 30459144DERIVED

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Carmen Enciu

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 20, 2015

Study Start

July 31, 2015

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

CA(20)