Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
NCT ID: NCT03271489
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2017-09-13
2024-06-28
Brief Summary
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Detailed Description
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1. Elagolix 300 mg twice daily (BID) plus estradiol 1.0 mg/norethindrone acetate 0.5 mg (E2/NETA) once daily (QD) for 48 months, followed by 12 months PTFU
2. Placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA QD for 36 months, followed by 12 months PTFU
This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Elagolix
Film-coated 300 mg tablets
Estradiol /norethindrone acetate (E2/NETA)
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
Placebo
E2/NETA Placebo
Placebo capsules
Elagolix Placebo
Film-coated placebo tablets
Interventions
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Elagolix
Film-coated 300 mg tablets
Estradiol /norethindrone acetate (E2/NETA)
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
E2/NETA Placebo
Placebo capsules
Elagolix Placebo
Film-coated placebo tablets
Eligibility Criteria
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Inclusion Criteria
* Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound \[Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)\].
* Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Participant has negative urine and/or serum pregnancy test during 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 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
50 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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Alabama Clinical Therapeutics /ID# 160835
Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 160927
Birmingham, Alabama, United States
Choice Research, LLC /ID# 161498
Dothan, Alabama, United States
Southern Women's Specialists PC /ID# 161531
Fairhope, Alabama, United States
E Squared Research /ID# 163645
Huntsville, Alabama, United States
Women's Health Alliance of Mobile /ID# 161443
Mobile, Alabama, United States
Mobile, OBGYN P.C. /ID# 161530
Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists /ID# 160955
Mesa, Arizona, United States
Noble Clinical Research /ID# 166949
Tucson, Arizona, United States
Vision's Clinical Research-Tucson /ID# 161508
Tucson, Arizona, United States
Eclipse Clinical Research /ID# 161516
Tucson, Arizona, United States
Duplicate_Core Healthcare Group /ID# 160858
Cerritos, California, United States
Diagnamics Inc. /ID# 160950
Encinitas, California, United States
HRC Fertility /ID# 161493
Encino, California, United States
SC Clinical Research /ID# 164395
Garden Grove, California, United States
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
Huntington Beach, California, United States
Grossmont Ctr Clin Research /ID# 165120
La Mesa, California, United States
Olympia Clinical Trials /ID# 201562
Los Angeles, California, United States
National Research Institute /ID# 160952
Los Angeles, California, United States
Futura Research, Org /ID# 160924
Montebello, California, United States
California Medical Research Associates /ID# 161481
Northridge, California, United States
Northern California Research /ID# 161561
Sacramento, California, United States
Precision Research Institute - San Diego /ID# 163069
San Diego, California, United States
MD Strategies Research Centers /ID# 161544
San Diego, California, United States
Health care Affiliates Medical Group /ID# 163324
Santa Ana, California, United States
Alta California Medical Group /ID# 163564
Simi Valley, California, United States
Upland Clinical Research /ID# 164528
Upland, California, United States
Bayview Research Group LLC /ID# 161484
Valley Village, California, United States
Advanced RX Clinical Research /ID# 161599
Westminster, California, United States
Emerson Clinical Research Inst /ID# 162181
Washington D.C., District of Columbia, United States
James A. Simon, MD, PC /ID# 160931
Washington D.C., District of Columbia, United States
Women's Health Partners /ID# 203577
Boca Raton, Florida, United States
David Lubetkin MD LLC /ID# 203578
Boca Raton, Florida, United States
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
Brandon, Florida, United States
Omega Research Maitland, LLC /ID# 160857
DeBary, Florida, United States
Midland Florida Clinical Research Center /ID# 161487
DeLand, Florida, United States
KO Clinical Research, LLC /ID# 160928
Fort Lauderdale, Florida, United States
Sweet Hope Research Specialty Inc /ID# 163522
Hialeah, Florida, United States
Solutions Through Adv Rch /ID# 160935
Jacksonville, Florida, United States
Altus Research, Inc /ID# 160912
Lake Worth, Florida, United States
Wellington Anti-Aging Centre /ID# 203540
Loxahatchee Groves, Florida, United States
South Florida Wellness & Clinic /ID# 161535
Margate, Florida, United States
Invictus Clinical Research Group,LLC /ID# 160925
Miami, Florida, United States
Healthcare Clinical Data, Inc /ID# 160888
Miami, Florida, United States
Palmetto Professional Research /ID# 161442
Miami, Florida, United States
Vista Health Research, LLC /ID# 163044
Miami, Florida, United States
Duplicate_Precision Research Organization /ID# 161522
Miami Lakes, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 161549
Miami Springs, Florida, United States
Salom Tangir, LLC /ID# 162542
Miramar, Florida, United States
Advanced Research Institute, Inc /ID# 163748
New Port Richey, Florida, United States
A Premier Medical Research of FL /ID# 201882
Orange City, Florida, United States
Clinical Associates of Orlando /ID# 160889
Orlando, Florida, United States
Oncova Clinical Research, Inc. /ID# 160937
Saint Cloud, Florida, United States
Physician Care Clin. Res., LLC /ID# 161547
Sarasota, Florida, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
St. Petersburg, Florida, United States
Treasure Coast Research /ID# 161824
Stuart, Florida, United States
Discovery Clinical Research /ID# 160891
Sunrise, Florida, United States
Precision Clinical Research /ID# 165377
Sunrise, Florida, United States
GCP Clinical Research, LLC /ID# 164593
Tampa, Florida, United States
University of South Florida- Neuroscience Institute /ID# 160960
Tampa, Florida, United States
Jedidiah Clinical Research /ID# 167114
Tampa, Florida, United States
Virtus Research Consultants, LLC /ID# 160855
Wellington, Florida, United States
Comprehensive Clinical Trials LLC /ID# 161479
West Palm Beach, Florida, United States
Journey Medical Research Insti /ID# 160958
Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 161557
Alpharetta, Georgia, United States
AGILE Clinical Research Trials /ID# 160941
Atlanta, Georgia, United States
Mount Vernon Clinical Res, LLC /ID# 161491
Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 160844
Atlanta, Georgia, United States
Medisense Inc /ID# 161494
Atlanta, Georgia, United States
Duplicate_Atlanta Gynecology Research Institute /ID# 160851
Suwanee, Georgia, United States
Bingham Memorial Hospital /ID# 201130
Blackfoot, Idaho, United States
Leavitt Womens Healthcare /ID# 163419
Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 160933
Idaho Falls, Idaho, United States
Sonora Clinical Research /ID# 167610
Meridian, Idaho, United States
Asr, Llc /Id# 162179
Nampa, Idaho, United States
Women's Health Practice, LLC /ID# 161553
Champaign, Illinois, United States
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
Chicago, Illinois, United States
Duplicate_University of Chicago /ID# 162667
Chicago, Illinois, United States
Alliance for Multispecialty Research, LLC /ID# 160932
Oak Brook, Illinois, United States
Women's Health Advantage /ID# 161537
Fort Wayne, Indiana, United States
Womens & Family Care, LLC dba /ID# 160890
Shawnee Mission, Kansas, United States
Bluegrass Clinical Research /ID# 163485
Louisville, Kentucky, United States
Clinical Trials Management, LLC - Covington /ID# 160838
Covington, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 160893
Covington, Louisiana, United States
Praetorian Pharmaceutical Research /ID# 161532
Marrero, Louisiana, United States
Ochsner Baptist Medical Centre /ID# 161507
New Orleans, Louisiana, United States
Women Under Study, LLC /ID# 163990
New Orleans, Louisiana, United States
Willis-Knighton Pediatric GI S /ID# 161534
Shreveport, Louisiana, United States
Exordia Medical Research, Inc /ID# 160853
Fall River, Massachusetts, United States
Duplicate_Great Lakes Research Group, Inc. /ID# 161511
Bay City, Michigan, United States
Wayne State University /ID# 160944
Detroit, Michigan, United States
Valley OB-Gyn Clinic - Saginaw /ID# 203579
Saginaw, Michigan, United States
Saginaw Valley Med Res Group /ID# 160840
Saginaw, Michigan, United States
Quad Clinical Research, LLC /ID# 200943
St Louis, Missouri, United States
Excel Clinical Research /ID# 165588
Las Vegas, Nevada, United States
Office of Edmond E. Pack, MD /ID# 162604
Las Vegas, Nevada, United States
Private practice: Dr. Rex G. Mabey JR /ID# 160915
Las Vegas, Nevada, United States
Jersey Shore University Medical Center /ID# 160916
Neptune City, New Jersey, United States
Lovelace Scientific Resources /ID# 163644
Albuquerque, New Mexico, United States
Bosque Women's Care /ID# 162606
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 160922
Brooklyn, New York, United States
Duplicate_Northwell Health System - Manhasset /ID# 201058
Manhasset, New York, United States
Columbia Univ Medical Center /ID# 161519
New York, New York, United States
Hamburg Regional Gynecology Gr /ID# 161427
Orchard Park, New York, United States
DJL Clinical Research, PLLC /ID# 161548
Charlotte, North Carolina, United States
Carolina Women's Research and Wellness Center /ID# 160914
Durham, North Carolina, United States
Unified Women's Clinical Resea /ID# 163014
Raleigh, North Carolina, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
Raleigh, North Carolina, United States
Unified Women's Clinical Resea /ID# 160957
Winston-Salem, North Carolina, United States
Clinical Inquest Center Ltd /ID# 160892
Beavercreek, Ohio, United States
Duplicate_CTI Clinical Research Center /ID# 160942
Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 160953
Cleveland, Ohio, United States
Central Ohio Clinical Research /ID# 201162
Columbus, Ohio, United States
Duplicate_Optimed Research /ID# 165600
Columbus, Ohio, United States
Hilltop Obstetrics & Gynecology /ID# 203576
Middletown, Ohio, United States
University of Toledo /ID# 160923
Toledo, Ohio, United States
Oregon Medical Research Center /ID# 161514
Portland, Oregon, United States
OB/GYN Associates of Erie /ID# 161541
Erie, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 160896
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 160936
Philadelphia, Pennsylvania, United States
DUP_Thomas Jefferson University /ID# 200304
Philadelphia, Pennsylvania, United States
Vista Clinical Research /ID# 160946
Columbia, South Carolina, United States
VitaLink Research-Spartanburg /ID# 164592
Spartanburg, South Carolina, United States
Duplicate_Chattanooga Medical Research /ID# 160885
Chattanooga, Tennessee, United States
WR-ClinSearch /ID# 160887
Chattanooga, Tennessee, United States
The Jackson Clinic, PA /ID# 162496
Jackson, Tennessee, United States
Research Memphis Associates, LLC /ID# 160939
Memphis, Tennessee, United States
OBGYN North /ID# 203580
Austin, Texas, United States
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
Austin, Texas, United States
Discovery Clinical Trials -HCWC /ID# 161543
Dallas, Texas, United States
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
Dallas, Texas, United States
Baylor Scott & White /ID# 161515
Fort Worth, Texas, United States
Willowbend Health and Wellness - Frisco /ID# 160954
Frisco, Texas, United States
The Ob/Gyn Center /ID# 165928
Houston, Texas, United States
Precision Research Institute, LLC /ID# 161554
Houston, Texas, United States
The Woman's Hospital of Texas /ID# 160959
Houston, Texas, United States
Centex Studies, Inc /ID# 163858
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 160917
Houston, Texas, United States
UAG Innovation Women Research, /ID# 167415
Houston, Texas, United States
America's Adv. Wellness Center /ID# 167548
Houston, Texas, United States
FMC Science /ID# 160886
Lampasas, Texas, United States
Advances in Health, Inc. /ID# 160930
Pearland, Texas, United States
ClinRx Research, LLC /ID# 201170
Plano, Texas, United States
Clinical Trials of Texas, Inc /ID# 161510
San Antonio, Texas, United States
VIP Trials /ID# 161546
San Antonio, Texas, United States
Houston Ctr for Clin Research /ID# 160837
Sugar Land, Texas, United States
The Univ Texas HSC at Tyler /ID# 161533
Tyler, Texas, United States
Center of Reproductive Medicine /ID# 162498
Webster, Texas, United States
Univ of Virgnia Medical center /ID# 166283
Charlottesville, Virginia, United States
Eastern Virginia Med School /ID# 160856
Norfolk, Virginia, United States
Clinical Research Partners /ID# 160929
North Chesterfield, Virginia, United States
Clinical Research Partners /ID# 160948
North Chesterfield, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 160943
Richmond, Virginia, United States
Specialists for Women /ID# 201129
Suffolk, Virginia, United States
Tidewater Clinical Research /ID# 160949
Virginia Beach, Virginia, United States
Henry A. Rodriguez Ginorio, MD /ID# 160861
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M16-283
Identifier Type: -
Identifier Source: org_study_id
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