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NCT02580578 Clinical Trial

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

Leiomyoma Clinical Trial

Official title:
A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02580578
Other study ID # CMO-CAN-WH-0412
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2015
Est. completion date January 31, 2020

Study information
Verified date February 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
No intervention is administered in this study.

Locations
Country Name City State
Canada Peter Lougheed Centre/University of Calgary Calgary Alberta
Canada Urestky Edmonton Clinic Edmonton Alberta
Canada Landau Fredericton Clinic Fredericton New Brunswick
Canada IWK Healtch Centre Halifax Nova Scotia
Canada Hamilton Health Sciences Hamilton Ontario
Canada Centre Gynécologie et Maternité Lasalle Quebec
Canada Minimally Invasive Gynecology Clinic London Ontario
Canada Clinique de Gynécologie & Obstétrique Pierre Boucher Montreal Quebec
Canada Jewish General Hospital Montreal Quebec
Canada Ottawa Hospital Research Institute Ottawa Ontario
Canada CHU de Québec-Universite Laval Québec
Canada University of Saskatchewan Regina Saskatchewan
Canada Complexe Medical Saint-Laurent Saint-Laurent Quebec
Canada Strand Clinic St. John Newfoundland and Labrador
Canada Mount Sinai Hospital Toronto Ontario
Canada St. Micheals Hospital Toronto Ontario
Canada Children's and Women's Health Centre of British Columbia - The University of British Columbia Vancouver British Columbia
Canada Sanders Vancouver Clinic Vancouver British Columbia
Canada Southern Health Centre White Rock British Columbia
Canada South Windsor Women's Health Windsor Ontario

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL) 24 Months
Primary Ruta Menorrhagia (Bleeding) 15-Item Questionnaire 24 Months
Primary Number of Participants with Adverse Drug Reactions 24 Months
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