Clinical trial NCT02580578: A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids
Official title: A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leiomyoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)
timeFrame: 24 Months
measure: Ruta Menorrhagia (Bleeding) 15-Item Questionnaire
timeFrame: 24 Months
measure: Number of Participants with Adverse Drug Reactions
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre/University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Urestky Edmonton Clinic
state: Alberta
city: Vancouver
country: Canada
facility: Sanders Vancouver Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia - The University of British Columbia
state: British Columbia
city: White Rock
country: Canada
facility: Southern Health Centre
state: British Columbia
city: Fredericton
country: Canada
facility: Landau Fredericton Clinic
state: New Brunswick
city: St. John
country: Canada
facility: Strand Clinic
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Healtch Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: Minimally Invasive Gynecology Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Micheals Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Windsor
country: Canada
facility: South Windsor Women's Health
state: Ontario
city: Lasalle
country: Canada
facility: Centre Gynécologie et Maternité
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Clinique de Gynécologie & Obstétrique Pierre Boucher
state: Quebec
city: Saint-Laurent
country: Canada
facility: Complexe Medical Saint-Laurent
state: Quebec
city: Regina
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Québec
country: Canada
facility: CHU de Québec-Universite Laval
Study officials:
affiliation: Allergan
name: Carmen Enciu
role: STUDY_DIRECTOR
References:
citation: Bougie O, Bedaiwy MA, Laberge P, Lebovic G, Leyland N, Atri M, Murji A; CAPTURE Steering Committee. Quality of ultrasonography reporting and factors associated with selection of imaging modality for uterine fibroids in Canada: results from a prospective cohort registry. CMAJ Open. 2020 Aug 12;8(3):E506-E513. doi: 10.9778/cmajo.20200004. Print 2020 Jul-Sep.
citation: Bedaiwy MA, Janiszewski P, Singh SS; CAPTURE Steering Committee. A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study. JMIR Res Protoc. 2018 Nov 20;7(11):e10926. doi: 10.2196/10926.