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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02580578
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Leiomyoma Other: No Intervention

Study Type : Observational
Actual Enrollment : 1501 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry
Actual Study Start Date : July 31, 2015
Estimated Primary Completion Date : February 13, 2020
Estimated Study Completion Date : February 13, 2020

Group/Cohort Intervention/treatment
All Participants
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.
Other: No Intervention
No intervention is administered in this study.




Primary Outcome Measures :
  1. Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL) [ Time Frame: 24 Months ]
  2. Ruta Menorrhagia (Bleeding) 15-Item Questionnaire [ Time Frame: 24 Months ]
  3. Number of Participants with Adverse Drug Reactions [ Time Frame: 24 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580578


Locations
Canada, Alberta
Peter Lougheed Centre/University of Calgary
Calgary, Alberta, Canada, T2E 7W7
Urestky Edmonton Clinic
Edmonton, Alberta, Canada, T5T 1L6
Canada, British Columbia
Sanders Vancouver Clinic
Vancouver, British Columbia, Canada, V5Z 4E1
Children's and Women's Health Centre of British Columbia - The University of British Columbia
Vancouver, British Columbia, Canada, V6H 3N1
Southern Health Centre
Whitbe Rock, British Columbia, Canada, V4B 5C9
Canada, New Brunswick
Landau Fredericton Clinic
Fredericton, New Brunswick, Canada, E3B 6H5
Canada, Newfoundland and Labrador
Strand Clinic
St. John, Newfoundland and Labrador, Canada, L6G 0B5
Canada, Nova Scotia
IWK Healtch Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8S 4K1
Minimally Invasive Gynecology Clinic
London, Ontario, Canada, N6A 5W9
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9
St. Micheals Hospital
Toronto, Ontario, Canada, M5C 2T2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5
South Windsor Women's Health
Windsor, Ontario, Canada, N9C 1X2
Canada, Quebec
Centre Gynécologie et Maternité
Lasalle, Quebec, Canada, H8N 1T9
Jewish General Hospital
Montreal, Quebec, Canada, H3S 1Y9
Clinique de Gynécologie & Obstétrique Pierre Boucher
Montreal, Quebec, Canada, J4N 1C2
Complexe Medical Saint-Laurent
Saint-Laurent, Quebec, Canada, H4R 0B7
Canada, Saskatchewan
University of Saskatchewan
Regina, Saskatchewan, Canada, S4S 6X3
Canada
CHU de Québec-Universite Laval
Québec, Canada, G1V 4G2
Sponsors and Collaborators
Allergan
Investigators
Study Director: Peter Janiszewski Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02580578     History of Changes
Other Study ID Numbers: CMO-CAN-WH-0412
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases