A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
NCT ID: NCT03886220
Last Updated: 2022-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2019-04-12
2021-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elagolix 150 mg
Elagolix 150 mg once daily (QD)
Elagolix
Oral; Tablet
Placebo
Placebo QD
Placebo
Oral; Tablet
Interventions
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Elagolix
Oral; Tablet
Placebo
Oral; Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) \> 80 mL during 1 menses in screening as measured by the alkaline hematin method.
* Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.
* Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.
Exclusion Criteria
* Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.
* Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
18 Years
51 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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ACCEL Research Sites /ID# 209714
Birmingham, Alabama, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
Birmingham, Alabama, United States
Unity Health- Searcy Medical Center /ID# 210905
Searcy, Arkansas, United States
Grossmont Ctr Clin Research /ID# 217690
La Mesa, California, United States
Women's Health Care Research Corp /ID# 211472
San Diego, California, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
Fort Myers, Florida, United States
Caceres Specialized Gynecology /ID# 214956
Kissimmee, Florida, United States
LCC Medical Research Institute /ID# 213765
Miami, Florida, United States
Genoma Research Group, Inc /ID# 213771
Miami, Florida, United States
A Premier Medical Research of FL /ID# 214947
Orange City, Florida, United States
GCP Clinical Research, LLC /ID# 218742
Tampa, Florida, United States
Comprehensive Clinical Trials LLC /ID# 217177
West Palm Beach, Florida, United States
Georgia Research for Women /ID# 211321
Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 217745
Atlanta, Georgia, United States
Medisense Inc /ID# 217750
Atlanta, Georgia, United States
Women's Health of Augusta /ID# 214995
Augusta, Georgia, United States
Midtown OBGYN North /ID# 209391
Columbus, Georgia, United States
Journey Medical Research Institute - Snellville /ID# 217309
Snellville, Georgia, United States
Affinity Clinical Research /ID# 215252
Oak Brook, Illinois, United States
Clinical Trials Management, LLC - Covington /ID# 215020
Covington, Louisiana, United States
Southern Clinical Research A /ID# 213732
Metairie, Louisiana, United States
Johns Hopkins University /ID# 211135
Baltimore, Maryland, United States
NECCR Fall River LLC /ID# 215009
Fall River, Massachusetts, United States
Excel Clinical Research /ID# 215936
Las Vegas, Nevada, United States
Manhattan Medical Research /ID# 213753
New York, New York, United States
Upstate Clinical Research Associates /ID# 215156
Williamsville, New York, United States
M3 Wake Research Inc. /ID# 215166
Raleigh, North Carolina, United States
Carolina Medical Trials - Winston-Salem /ID# 215027
Winston-Salem, North Carolina, United States
Legacy Medical Group-Gynecologic Oncology /ID# 211016
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC /ID# 213741
Philadelphia, Pennsylvania, United States
Reading Hospital Clinical Trials Office /ID# 213763
West Reading, Pennsylvania, United States
Clinical Trials of SC /ID# 210204
Charleston, South Carolina, United States
Chattanooga Medical Research /ID# 215294
Chattanooga, Tennessee, United States
WR-Medical Research Center of Memphis LLC /ID# 213756
Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 215357
Nashville, Tennessee, United States
Signature Gyn Services /ID# 213883
Fort Worth, Texas, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
Georgetown, Texas, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
Houston, Texas, United States
Advances in Health, Inc. /ID# 215847
Houston, Texas, United States
Clinical Trials of Texas, Inc /ID# 213768
San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 214996
San Antonio, Texas, United States
Storks Research, LLC /ID# 211146
Sugar Land, Texas, United States
Houston Ctr for Clin Research /ID# 215138
Sugar Land, Texas, United States
Seattle Clinical Research Center /ID# 210853
Seattle, Washington, United States
North Spokane Women's Health /ID# 209889
Spokane, Washington, United States
Emanuelli Research & Development Center LLC /ID# 212715
Arecibo, , Puerto Rico
Puerto Rico Medical Research /ID# 212841
Ponce, , Puerto Rico
Mindful Medical Research /ID# 212496
San Juan, , Puerto Rico
Countries
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References
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Brown E, Kroll R, Li H, Ng J, Pinsky B, Rodriguez JW, Thomas J, Snabes MC. Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1068-1076. doi: 10.1097/AOG.0000000000005380. Epub 2023 Sep 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M16-824
Identifier Type: -
Identifier Source: org_study_id
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