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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02580578

Enrollment

1500

Registered

2015-10-20

Start date

2015-07-31

Completion date

2020-01-31

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma

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.

Interventions

OTHERNo Intervention

No intervention is administered in this study.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026