Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada

NCT ID: NCT04080856

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-04

Study Completion Date

2021-09-27

Brief Summary

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The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with endometriosis

Premenopausal participants with endometriosis receiving elagolix in real-world setting

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Prescribed elagolix as part of standard treatment
* Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study
* Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea
* Has provided written informed consent allowing the use of their data for the study

Exclusion Criteria

* Did not consent
* Cannot fill out questionnaires
* Prescribed elagolix for a period of 1 or 2 months only
* Post-menopausal (naturally or surgically)
* Symptomatic uterine fibroid(s)
* Had medical treatment for uterine fibroids (any length of treatment)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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South Health Campus Rheumatology Clinic /ID# 213065

Calgary, Alberta, Canada

Site Status

Aubrey D. Uretsky Professional Corporation /ID# 214753

Edmonton, Alberta, Canada

Site Status

BC Women's Hospital /ID# 214561

Vancouver, British Columbia, Canada

Site Status

Strand Clinic /ID# 213567

St. John's, Newfoundland and Labrador, Canada

Site Status

IWK Health Center /ID# 213066

Halifax, Nova Scotia, Canada

Site Status

Medicor Research Inc /ID# 213467

Greater Sudbury, Ontario, Canada

Site Status

Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496

Hamilton, Ontario, Canada

Site Status

Dr. George A. Vilos Medicine Professional Corporation /ID# 214497

London, Ontario, Canada

Site Status

Ottawa Hospital Research Institute /ID# 213608

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Ctr /ID# 214330

Toronto, Ontario, Canada

Site Status

Unity Health Toronto - St. Michael's Hospital /ID# 213590

Toronto, Ontario, Canada

Site Status

CISSS - Hôpital de Gatineau /ID# 212944

Gatineau, Quebec, Canada

Site Status

Jessima R&D Inc. /ID# 212943

LaSalle, Quebec, Canada

Site Status

Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064

Longueuil, Quebec, Canada

Site Status

CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439

Montreal, Quebec, Canada

Site Status

Jewish General Hospital /ID# 215728

Montreal, Quebec, Canada

Site Status

Duplicate_Brunswick Medical /ID# 214743

Montreal, Quebec, Canada

Site Status

CHU de Quebec-Université Laval hôpital CHUL /ID# 213677

Québec, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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P19-933

Identifier Type: -

Identifier Source: org_study_id

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