A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids
- Conditions
- Leiomyoma
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1500
-Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment.
-Significant pelvic pathology not associated with uterine fibroids.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Peter Lougheed Centre/University of Calgary
🇨🇦Calgary, Alberta, Canada
Urestky Edmonton Clinic
🇨🇦Edmonton, Alberta, Canada
Sanders Vancouver Clinic
🇨🇦Vancouver, British Columbia, Canada
Children's and Women's Health Centre of British Columbia - The University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Southern Health Centre
🇨🇦White Rock, British Columbia, Canada
Landau Fredericton Clinic
🇨🇦Fredericton, New Brunswick, Canada
Strand Clinic
🇨🇦St. John, Newfoundland and Labrador, Canada
IWK Healtch Centre
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Minimally Invasive Gynecology Clinic
🇨🇦London, Ontario, Canada
Scroll for more (10 remaining)Peter Lougheed Centre/University of Calgary🇨🇦Calgary, Alberta, Canada