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
A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
1 other identifier
interventional
478
2 countries
157
Brief Summary
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2017
Longer than P75 for phase_3
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedStudy Start
First participant enrolled
September 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedResults Posted
Study results publicly available
July 22, 2025
CompletedJuly 22, 2025
July 1, 2025
6.8 years
August 31, 2017
June 13, 2025
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Baseline to 60 months
Secondary Outcomes (1)
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Baseline through Month 60
Study Arms (2)
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
Eligibility Criteria
You may qualify if:
- Participant is a premenopausal female at the time of Screening.
- 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.
You may not qualify if:
- Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (157)
Alabama Clinical Therapeutics /ID# 160835
Birmingham, Alabama, 35235-3430, United States
Alabama Clinical Therapeutics /ID# 160927
Birmingham, Alabama, 35235-3430, United States
Choice Research, LLC /ID# 161498
Dothan, Alabama, 36303, United States
Southern Women's Specialists PC /ID# 161531
Fairhope, Alabama, 36532-3029, United States
E Squared Research /ID# 163645
Huntsville, Alabama, 35801, United States
Women's Health Alliance of Mobile /ID# 161443
Mobile, Alabama, 36604-1410, United States
Mobile, OBGYN P.C. /ID# 161530
Mobile, Alabama, 36608, United States
Mesa Obstetricians and Gynecologists /ID# 160955
Mesa, Arizona, 85209, United States
Noble Clinical Research /ID# 166949
Tucson, Arizona, 85704, United States
Vision's Clinical Research-Tucson /ID# 161508
Tucson, Arizona, 85712, United States
Eclipse Clinical Research /ID# 161516
Tucson, Arizona, 85745, United States
Duplicate_Core Healthcare Group /ID# 160858
Cerritos, California, 90703, United States
Diagnamics Inc. /ID# 160950
Encinitas, California, 92024, United States
HRC Fertility /ID# 161493
Encino, California, 91436, United States
SC Clinical Research /ID# 164395
Garden Grove, California, 92844, United States
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
Huntington Beach, California, 92647, United States
Grossmont Ctr Clin Research /ID# 165120
La Mesa, California, 91942, United States
Olympia Clinical Trials /ID# 201562
Los Angeles, California, 90036-4667, United States
National Research Institute /ID# 160952
Los Angeles, California, 90057, United States
Futura Research, Org /ID# 160924
Montebello, California, 90640, United States
California Medical Research Associates /ID# 161481
Northridge, California, 91324, United States
Northern California Research /ID# 161561
Sacramento, California, 95821-2640, United States
Precision Research Institute - San Diego /ID# 163069
San Diego, California, 92114-3643, United States
MD Strategies Research Centers /ID# 161544
San Diego, California, 92119, United States
Health care Affiliates Medical Group /ID# 163324
Santa Ana, California, 92704, United States
Alta California Medical Group /ID# 163564
Simi Valley, California, 93065, United States
Upland Clinical Research /ID# 164528
Upland, California, 91786-4027, United States
Bayview Research Group LLC /ID# 161484
Valley Village, California, 91607, United States
Advanced RX Clinical Research /ID# 161599
Westminster, California, 92683-4567, United States
Emerson Clinical Research Inst /ID# 162181
Washington D.C., District of Columbia, 20011, United States
James A. Simon, MD, PC /ID# 160931
Washington D.C., District of Columbia, 20036, United States
Women's Health Partners /ID# 203577
Boca Raton, Florida, 33433-7041, United States
David Lubetkin MD LLC /ID# 203578
Boca Raton, Florida, 33486-2269, United States
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
Brandon, Florida, 33510-3107, United States
Omega Research Maitland, LLC /ID# 160857
DeBary, Florida, 32713-2260, United States
Midland Florida Clinical Research Center /ID# 161487
DeLand, Florida, 32720-0920, United States
KO Clinical Research, LLC /ID# 160928
Fort Lauderdale, Florida, 33316, United States
Sweet Hope Research Specialty Inc /ID# 163522
Hialeah, Florida, 33016-1897, United States
Solutions Through Adv Rch /ID# 160935
Jacksonville, Florida, 32256, United States
Altus Research, Inc /ID# 160912
Lake Worth, Florida, 33461, United States
Wellington Anti-Aging Centre /ID# 203540
Loxahatchee Groves, Florida, 33470-4937, United States
South Florida Wellness & Clinic /ID# 161535
Margate, Florida, 33063, United States
Invictus Clinical Research Group,LLC /ID# 160925
Miami, Florida, 33144, United States
Healthcare Clinical Data, Inc /ID# 160888
Miami, Florida, 33161, United States
Palmetto Professional Research /ID# 161442
Miami, Florida, 33172, United States
Vista Health Research, LLC /ID# 163044
Miami, Florida, 33176-1032, United States
Duplicate_Precision Research Organization /ID# 161522
Miami Lakes, Florida, 33016-1501, United States
Ocean Blue Medical Research Center, Inc /ID# 161549
Miami Springs, Florida, 33166, United States
Salom Tangir, LLC /ID# 162542
Miramar, Florida, 33027, United States
Advanced Research Institute, Inc /ID# 163748
New Port Richey, Florida, 34653, United States
A Premier Medical Research of FL /ID# 201882
Orange City, Florida, 32763-2833, United States
Clinical Associates of Orlando /ID# 160889
Orlando, Florida, 32819-8900, United States
Oncova Clinical Research, Inc. /ID# 160937
Saint Cloud, Florida, 34769, United States
Physician Care Clin. Res., LLC /ID# 161547
Sarasota, Florida, 34239, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
St. Petersburg, Florida, 33709-3113, United States
Treasure Coast Research /ID# 161824
Stuart, Florida, 34996, United States
Discovery Clinical Research /ID# 160891
Sunrise, Florida, 33324, United States
Precision Clinical Research /ID# 165377
Sunrise, Florida, 33351-7311, United States
GCP Clinical Research, LLC /ID# 164593
Tampa, Florida, 33609-4044, United States
University of South Florida- Neuroscience Institute /ID# 160960
Tampa, Florida, 33613, United States
Jedidiah Clinical Research /ID# 167114
Tampa, Florida, 33617, United States
Virtus Research Consultants, LLC /ID# 160855
Wellington, Florida, 33414, United States
Comprehensive Clinical Trials LLC /ID# 161479
West Palm Beach, Florida, 33409, United States
Journey Medical Research Insti /ID# 160958
Alpharetta, Georgia, 30005, United States
Paramount Research Solutions /ID# 161557
Alpharetta, Georgia, 30005, United States
AGILE Clinical Research Trials /ID# 160941
Atlanta, Georgia, 30328-5532, United States
Mount Vernon Clinical Res, LLC /ID# 161491
Atlanta, Georgia, 30328, United States
Atlanta Women's Research Institute /ID# 160844
Atlanta, Georgia, 30342, United States
Medisense Inc /ID# 161494
Atlanta, Georgia, 30363, United States
Duplicate_Atlanta Gynecology Research Institute /ID# 160851
Suwanee, Georgia, 30024-7159, United States
Bingham Memorial Hospital /ID# 201130
Blackfoot, Idaho, 83221, United States
Leavitt Womens Healthcare /ID# 163419
Idaho Falls, Idaho, 83404, United States
Womens Healthcare Assoc, DBA /ID# 160933
Idaho Falls, Idaho, 83404, United States
Sonora Clinical Research /ID# 167610
Meridian, Idaho, 83646-1144, United States
Asr, Llc /Id# 162179
Nampa, Idaho, 83687, United States
Women's Health Practice, LLC /ID# 161553
Champaign, Illinois, 61820, United States
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
Chicago, Illinois, 60605-2168, United States
Duplicate_University of Chicago /ID# 162667
Chicago, Illinois, 60637, United States
Alliance for Multispecialty Research, LLC /ID# 160932
Oak Brook, Illinois, 60523, United States
Women's Health Advantage /ID# 161537
Fort Wayne, Indiana, 46825, United States
Womens & Family Care, LLC dba /ID# 160890
Shawnee Mission, Kansas, 66218, United States
Bluegrass Clinical Research /ID# 163485
Louisville, Kentucky, 40291-1988, United States
Clinical Trials Management, LLC - Covington /ID# 160838
Covington, Louisiana, 70433, United States
Clinical Trials Management, LLC - Covington /ID# 160893
Covington, Louisiana, 70433, United States
Praetorian Pharmaceutical Research /ID# 161532
Marrero, Louisiana, 70072, United States
Ochsner Baptist Medical Centre /ID# 161507
New Orleans, Louisiana, 70115, United States
Women Under Study, LLC /ID# 163990
New Orleans, Louisiana, 70125-1923, United States
Willis-Knighton Pediatric GI S /ID# 161534
Shreveport, Louisiana, 71118, United States
Exordia Medical Research, Inc /ID# 160853
Fall River, Massachusetts, 02723, United States
Duplicate_Great Lakes Research Group, Inc. /ID# 161511
Bay City, Michigan, 48602, United States
Wayne State University /ID# 160944
Detroit, Michigan, 48201-2013, United States
Valley OB-Gyn Clinic - Saginaw /ID# 203579
Saginaw, Michigan, 48602-4323, United States
Saginaw Valley Med Res Group /ID# 160840
Saginaw, Michigan, 48604, United States
Quad Clinical Research, LLC /ID# 200943
St Louis, Missouri, 63109, United States
Excel Clinical Research /ID# 165588
Las Vegas, Nevada, 89109, United States
Office of Edmond E. Pack, MD /ID# 162604
Las Vegas, Nevada, 89113, United States
Private practice: Dr. Rex G. Mabey JR /ID# 160915
Las Vegas, Nevada, 89128, United States
Jersey Shore University Medical Center /ID# 160916
Neptune City, New Jersey, 07753-4859, United States
Lovelace Scientific Resources /ID# 163644
Albuquerque, New Mexico, 87108, United States
Bosque Women's Care /ID# 162606
Albuquerque, New Mexico, 87109, United States
SUNY Downstate Medical Center /ID# 160922
Brooklyn, New York, 11203, United States
Duplicate_Northwell Health System - Manhasset /ID# 201058
Manhasset, New York, 11030-3816, United States
Columbia Univ Medical Center /ID# 161519
New York, New York, 10032-3725, United States
Hamburg Regional Gynecology Gr /ID# 161427
Orchard Park, New York, 14127, United States
DJL Clinical Research, PLLC /ID# 161548
Charlotte, North Carolina, 28211, United States
Carolina Women's Research and Wellness Center /ID# 160914
Durham, North Carolina, 27713-7512, United States
Unified Women's Clinical Resea /ID# 163014
Raleigh, North Carolina, 27607, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
Raleigh, North Carolina, 27612, United States
Unified Women's Clinical Resea /ID# 160957
Winston-Salem, North Carolina, 27103, United States
Clinical Inquest Center Ltd /ID# 160892
Beavercreek, Ohio, 45431-2573, United States
Duplicate_CTI Clinical Research Center /ID# 160942
Cincinnati, Ohio, 45212, United States
Univ Hosp Cleveland /ID# 160953
Cleveland, Ohio, 44106, United States
Central Ohio Clinical Research /ID# 201162
Columbus, Ohio, 43213-3399, United States
Duplicate_Optimed Research /ID# 165600
Columbus, Ohio, 43235, United States
Hilltop Obstetrics & Gynecology /ID# 203576
Middletown, Ohio, 45005-5200, United States
University of Toledo /ID# 160923
Toledo, Ohio, 43614, United States
Oregon Medical Research Center /ID# 161514
Portland, Oregon, 97239, United States
OB/GYN Associates of Erie /ID# 161541
Erie, Pennsylvania, 16507-1423, United States
Penn State University and Milton S. Hershey Medical Center /ID# 160896
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania /ID# 160936
Philadelphia, Pennsylvania, 19104-5502, United States
DUP_Thomas Jefferson University /ID# 200304
Philadelphia, Pennsylvania, 19107, United States
Vista Clinical Research /ID# 160946
Columbia, South Carolina, 29201, United States
VitaLink Research-Spartanburg /ID# 164592
Spartanburg, South Carolina, 29303, United States
Duplicate_Chattanooga Medical Research /ID# 160885
Chattanooga, Tennessee, 37404, United States
WR-ClinSearch /ID# 160887
Chattanooga, Tennessee, 37421-1605, United States
The Jackson Clinic, PA /ID# 162496
Jackson, Tennessee, 38305, United States
Research Memphis Associates, LLC /ID# 160939
Memphis, Tennessee, 38119-3895, United States
OBGYN North /ID# 203580
Austin, Texas, 78758-5444, United States
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
Austin, Texas, 78758-5653, United States
Discovery Clinical Trials -HCWC /ID# 161543
Dallas, Texas, 75230-2571, United States
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
Dallas, Texas, 75390-8575, United States
Baylor Scott & White /ID# 161515
Fort Worth, Texas, 76104-4110, United States
Willowbend Health and Wellness - Frisco /ID# 160954
Frisco, Texas, 75035, United States
The Ob/Gyn Center /ID# 165928
Houston, Texas, 77030, United States
Precision Research Institute, LLC /ID# 161554
Houston, Texas, 77036, United States
The Woman's Hospital of Texas /ID# 160959
Houston, Texas, 77054, United States
Centex Studies, Inc /ID# 163858
Houston, Texas, 77058-2705, United States
Centex Studies, Inc. - Houston /ID# 160917
Houston, Texas, 77058, United States
UAG Innovation Women Research, /ID# 167415
Houston, Texas, 77074, United States
America's Adv. Wellness Center /ID# 167548
Houston, Texas, 77080, United States
FMC Science /ID# 160886
Lampasas, Texas, 76550, United States
Advances in Health, Inc. /ID# 160930
Pearland, Texas, 77854, United States
ClinRx Research, LLC /ID# 201170
Plano, Texas, 75024-5280, United States
Clinical Trials of Texas, Inc /ID# 161510
San Antonio, Texas, 78229, United States
VIP Trials /ID# 161546
San Antonio, Texas, 78230, United States
Houston Ctr for Clin Research /ID# 160837
Sugar Land, Texas, 77479, United States
The Univ Texas HSC at Tyler /ID# 161533
Tyler, Texas, 75708, United States
Center of Reproductive Medicine /ID# 162498
Webster, Texas, 77598, United States
Univ of Virgnia Medical center /ID# 166283
Charlottesville, Virginia, 22908-0816, United States
Eastern Virginia Med School /ID# 160856
Norfolk, Virginia, 23507-1627, United States
Clinical Research Partners /ID# 160929
North Chesterfield, Virginia, 23235, United States
Clinical Research Partners /ID# 160948
North Chesterfield, Virginia, 23235, United States
Clinical Trials Virginia, Inc. /ID# 160943
Richmond, Virginia, 23225, United States
Specialists for Women /ID# 201129
Suffolk, Virginia, 23434-8151, United States
Tidewater Clinical Research /ID# 160949
Virginia Beach, Virginia, 23456, United States
Henry A. Rodriguez Ginorio, MD /ID# 160861
San Juan, 00917-5022, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
San Juan, 00935, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2017
First Posted
September 5, 2017
Study Start
September 13, 2017
Primary Completion
June 28, 2024
Study Completion
June 28, 2024
Last Updated
July 22, 2025
Results First Posted
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.