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

Completed

• Conditions: Leiomyoma
• Interventions: Other: No Intervention

• Registration Number: NCT02580578
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Children's and Women's Health Centre of British Columbia - The University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Minimally Invasive Gynecology Clinic; 🇨🇦 London, Ontario, Canada

Peter Lougheed Centre/University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Urestky Edmonton Clinic; 🇨🇦 Edmonton, Alberta, Canada

Sanders Vancouver Clinic; 🇨🇦 Vancouver, British Columbia, Canada

IWK Healtch Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Southern Health Centre; 🇨🇦 White Rock, British Columbia, Canada

Landau Fredericton Clinic; 🇨🇦 Fredericton, New Brunswick, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

Clinique de Gynécologie & Obstétrique Pierre Boucher; 🇨🇦 Montreal, Quebec, Canada

Complexe Medical Saint-Laurent; 🇨🇦 Saint-Laurent, Quebec, Canada

St. Micheals Hospital; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

South Windsor Women's Health; 🇨🇦 Windsor, Ontario, Canada

Centre Gynécologie et Maternité; 🇨🇦 Lasalle, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Strand Clinic; 🇨🇦 St. John, Newfoundland and Labrador, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

University of Saskatchewan; 🇨🇦 Regina, Saskatchewan, Canada

CHU de Québec-Universite Laval; 🇨🇦 Québec, Canada