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

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.

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Peter Lougheed Centre/University of Calgary, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention is administered in this study.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2020
First posted: Oct 20, 2015
Registry last updated: Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed