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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

Tracking Information
First Submitted Date October 19, 2015
First Posted Date October 20, 2015
Last Update Posted Date February 28, 2020
Actual Study Start Date July 31, 2015
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2015)
  • Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL) [ Time Frame: 24 Months ]
  • Ruta Menorrhagia (Bleeding) 15-Item Questionnaire [ Time Frame: 24 Months ]
  • Number of Participants with Adverse Drug Reactions [ Time Frame: 24 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients diagnosed with uterine fibroids treated as per standard of care in clinical practice.
Condition Leiomyoma
Intervention Other: No Intervention
No intervention is administered in this study.
Study Groups/Cohorts 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.
Intervention: Other: No Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 15, 2019)
1500
Original Estimated Enrollment
 (submitted: October 19, 2015)
1000
Actual Study Completion Date January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02580578
Other Study ID Numbers CMO-CAN-WH-0412
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Carmen Enciu Allergan
PRS Account Allergan
Verification Date February 2020