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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 : Completed
First Posted : October 20, 2015
Last Update Posted : February 28, 2020
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

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Study Type : Observational
Actual Enrollment : 1500 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
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 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
Show Show 20 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Carmen Enciu Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02580578    
Other Study ID Numbers: CMO-CAN-WH-0412
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases