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

Allergan1,500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Leiomyoma

Interventions

No InterventionOTHER

No intervention is administered in this study.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Peter Lougheed Centre/University of Calgary

Calgary, Alberta, Canada

Urestky Edmonton Clinic

Outcomes

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

Data from ClinicalTrials.gov

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