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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

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: NCT03271489
Recruitment Status : Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : February 16, 2023
Information provided by (Responsible Party):

Brief Summary:
This is 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 is double-blinded in the first year and an open-label for the next three years.

Condition or disease Intervention/treatment Phase
Heavy Menstrual Bleeding Uterine Fibroids Other: Elagolix Placebo Drug: E2/NETA Other: E2/NETA Placebo Drug: Elagolix Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : November 27, 2023
Estimated Study Completion Date : July 2, 2024

Arm Intervention/treatment
Experimental: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Drug: E2/NETA

Drug: Elagolix
Other Name: ABT-620 Elagolix sodium

Placebo Comparator: Placebo
Other: Elagolix Placebo

Other: E2/NETA Placebo

Primary Outcome Measures :
  1. Change in Bone Mineral Density (BMD) [ Time Frame: From Baseline through Month 48 ]
    Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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) and 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271489

Hide Hide 157 study locations
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United States, Alabama
Alabama Clinical Therapeutics /ID# 160835
Birmingham, Alabama, United States, 35235-3430
Alabama Clinical Therapeutics /ID# 160927
Birmingham, Alabama, United States, 35235-3430
Choice Research, LLC /ID# 161498
Dothan, Alabama, United States, 36303
Southern Women's Specialists PC /ID# 161531
Fairhope, Alabama, United States, 36532-3029
E Squared Research /ID# 163645
Huntsville, Alabama, United States, 35801
Women's Health Alliance of Mobile /ID# 161443
Mobile, Alabama, United States, 36604-1410
Mobile, OBGYN P.C. /ID# 161530
Mobile, Alabama, United States, 36608
United States, Arizona
Mesa Obstetricians and Gynecologists /ID# 160955
Mesa, Arizona, United States, 85209
Noble Clinical Research /ID# 166949
Tucson, Arizona, United States, 85704
Vision's Clinical Research-Tucson /ID# 161508
Tucson, Arizona, United States, 85712
Eclipse Clinical Research /ID# 161516
Tucson, Arizona, United States, 85745
United States, California
Core Healthcare Group /ID# 160858
Cerritos, California, United States, 90703
Diagnamics Inc. /ID# 160950
Encinitas, California, United States, 92024
HRC Fertility /ID# 161493
Encino, California, United States, 91436
SC Clinical Research /ID# 164395
Garden Grove, California, United States, 92844
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
Huntington Beach, California, United States, 92647
Grossmont Ctr Clin Research /ID# 165120
La Mesa, California, United States, 91942
Olympia Clinical Trials /ID# 201562
Los Angeles, California, United States, 90036-4667
National Research Institute /ID# 160952
Los Angeles, California, United States, 90057
Futura Research, Org /ID# 160924
Montebello, California, United States, 90640
California Medical Research Associates /ID# 161481
Northridge, California, United States, 91324
Northern California Research /ID# 161561
Sacramento, California, United States, 95821-2640
Precision Research Institute - San Diego /ID# 163069
San Diego, California, United States, 92114-3643
MD Strategies Research Centers /ID# 161544
San Diego, California, United States, 92119
Health care Affiliates Medical Group /ID# 163324
Santa Ana, California, United States, 92704
Alta California Medical Group /ID# 163564
Simi Valley, California, United States, 93065
Upland Clinical Research /ID# 164528
Upland, California, United States, 91786-4027
Bayview Research Group LLC /ID# 161484
Valley Village, California, United States, 91607
Advanced RX Clinical Research /ID# 161599
Westminster, California, United States, 92683-4567
United States, District of Columbia
Emerson Clinical Research Inst /ID# 162181
Washington, District of Columbia, United States, 20011
James A. Simon, MD, PC /ID# 160931
Washington, District of Columbia, United States, 20036
United States, Florida
Women's Health Partners /ID# 203577
Boca Raton, Florida, United States, 33433-7041
David Lubetkin MD LLC /ID# 203578
Boca Raton, Florida, United States, 33486-2269
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
Brandon, Florida, United States, 33510-3107
Omega Research Maitland, LLC /ID# 160857
DeBary, Florida, United States, 32713-2260
Midland Florida Clinical Research Center /ID# 161487
DeLand, Florida, United States, 32720-0920
KO Clinical Research, LLC /ID# 160928
Fort Lauderdale, Florida, United States, 33316
Sweet Hope Research Specialty Inc /ID# 163522
Hialeah, Florida, United States, 33016-1897
Solutions Through Adv Rch /ID# 160935
Jacksonville, Florida, United States, 32256
Altus Research, Inc /ID# 160912
Lake Worth, Florida, United States, 33461
Wellington Anti-Aging Centre /ID# 203540
Loxahatchee Groves, Florida, United States, 33470-4937
South Florida Wellness & Clinic /ID# 161535
Margate, Florida, United States, 33063
Duplicate_Precision Research Organization /ID# 161522
Miami Lakes, Florida, United States, 33016-1501
Ocean Blue Medical Research Center, Inc /ID# 161549
Miami Springs, Florida, United States, 33166
Invictus Clinical Research Group,LLC /ID# 160925
Miami, Florida, United States, 33144
Healthcare Clinical Data, Inc /ID# 160888
Miami, Florida, United States, 33161
Palmetto Professional Research /ID# 161442
Miami, Florida, United States, 33172
Vista Health Research, LLC /ID# 163044
Miami, Florida, United States, 33176-1032
Salom Tangir, LLC /ID# 162542
Miramar, Florida, United States, 33027
Advanced Research Institute, Inc /ID# 163748
New Port Richey, Florida, United States, 34653
A Premier Medical Research of FL /ID# 201882
Orange City, Florida, United States, 32763-2833
Clinical Associates of Orlando /ID# 160889
Orlando, Florida, United States, 32819-8900
Oncova Clinical Research, Inc. /ID# 160937
Saint Cloud, Florida, United States, 34769
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
Saint Petersburg, Florida, United States, 33709-3113
Physician Care Clin. Res., LLC /ID# 161547
Sarasota, Florida, United States, 34239
Treasure Coast Research /ID# 161824
Stuart, Florida, United States, 34996
Discovery Clinical Research /ID# 160891
Sunrise, Florida, United States, 33324
Precision Clinical Research /ID# 165377
Sunrise, Florida, United States, 33351-7311
GCP Clinical Research, LLC /ID# 164593
Tampa, Florida, United States, 33609-4044
University of South Florida /ID# 160960
Tampa, Florida, United States, 33612
Jedidiah Clinical Research /ID# 167114
Tampa, Florida, United States, 33617
Virtus Research Consultants, LLC /ID# 160855
Wellington, Florida, United States, 33414
Comprehensive Clinical Trials LLC /ID# 161479
West Palm Beach, Florida, United States, 33409
United States, Georgia
Journey Medical Research Insti /ID# 160958
Alpharetta, Georgia, United States, 30005
Paramount Research Solutions /ID# 161557
Alpharetta, Georgia, United States, 30005
Agile Clinical Research Trials /ID# 160941
Atlanta, Georgia, United States, 30328-5532
Mount Vernon Clinical Res, LLC /ID# 161491
Atlanta, Georgia, United States, 30328
Atlanta Women's Research Institute /ID# 160844
Atlanta, Georgia, United States, 30342
Medisense Inc /ID# 161494
Atlanta, Georgia, United States, 30363
Duplicate_Atlanta Gynecology Research Institute /ID# 160851
Suwanee, Georgia, United States, 30024-7159
United States, Idaho
Bingham Memorial Hospital /ID# 201130
Blackfoot, Idaho, United States, 83221
Leavitt Womens Healthcare /ID# 163419
Idaho Falls, Idaho, United States, 83404-8322
Womens Healthcare Assoc, DBA /ID# 160933
Idaho Falls, Idaho, United States, 83404
Sonora Clinical Research /ID# 167610
Meridian, Idaho, United States, 83646-1144
Asr, Llc /Id# 162179
Nampa, Idaho, United States, 83687
United States, Illinois
Women's Health Practice, LLC /ID# 161553
Champaign, Illinois, United States, 61820
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
Chicago, Illinois, United States, 60605-2168
Duplicate_University of Chicago /ID# 162667
Chicago, Illinois, United States, 60637
Affinity Clinical Research /ID# 160932
Oak Brook, Illinois, United States, 60523-1245
United States, Indiana
Women's Health Advantage /ID# 161537
Fort Wayne, Indiana, United States, 46825
United States, Kansas
Womens & Family Care, LLC dba /ID# 160890
Shawnee Mission, Kansas, United States, 66218
United States, Kentucky
Bluegrass Clinical Research /ID# 163485
Louisville, Kentucky, United States, 40291-1988
United States, Louisiana
Clinical Trials Management, LLC - Covington /ID# 160838
Covington, Louisiana, United States, 70433
Clinical Trials Management, LLC - Covington /ID# 160893
Covington, Louisiana, United States, 70433
Praetorian Pharmaceutical Research /ID# 161532
Marrero, Louisiana, United States, 70072
Ochsner Baptist Medical Centre /ID# 161507
New Orleans, Louisiana, United States, 70115
Women Under Study, LLC /ID# 163990
New Orleans, Louisiana, United States, 70125-1923
Willis-Knighton Pediatric GI S /ID# 161534
Shreveport, Louisiana, United States, 71118
United States, Massachusetts
Exordia Medical Research, Inc /ID# 160853
Fall River, Massachusetts, United States, 02723
United States, Michigan
Great Lakes Research Group, Inc. /ID# 161511
Bay City, Michigan, United States, 48602
Wayne State University /ID# 160944
Detroit, Michigan, United States, 48201-2013
Valley OB-Gyn Clinic - Saginaw /ID# 203579
Saginaw, Michigan, United States, 48602-4323
Saginaw Valley Med Res Group /ID# 160840
Saginaw, Michigan, United States, 48604
United States, Missouri
Quad Clinical Research, LLC /ID# 200943
Saint Louis, Missouri, United States, 63109
United States, Nevada
Excel Clinical Research /ID# 165588
Las Vegas, Nevada, United States, 89109
Office of Edmond E. Pack, MD /ID# 162604
Las Vegas, Nevada, United States, 89113
Private practice: Dr. Rex G. Mabey JR /ID# 160915
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Jersey Shore University Medical Center /ID# 160916
Neptune, New Jersey, United States, 07753-4859
United States, New Mexico
Lovelace Scientific Resources /ID# 163644
Albuquerque, New Mexico, United States, 87108
Bosque Women's Care /ID# 162606
Albuquerque, New Mexico, United States, 87109
United States, New York
SUNY Downstate Medical Center /ID# 160922
Brooklyn, New York, United States, 11203
Duplicate_Northwell Health System - Manhasset /ID# 201058
Manhasset, New York, United States, 11030-3816
Columbia Univ Medical Center /ID# 161519
New York, New York, United States, 10032-3725
Hamburg Regional Gynecology Gr /ID# 161427
Orchard Park, New York, United States, 14127
United States, North Carolina
DJL Clinical Research, PLLC /ID# 161548
Charlotte, North Carolina, United States, 28211
Carolina Women's Research and Wellness Center /ID# 160914
Durham, North Carolina, United States, 27713-7512
Unified Women's Clinical Resea /ID# 163014
Raleigh, North Carolina, United States, 27607
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
Raleigh, North Carolina, United States, 27612
Unified Women's Clinical Resea /ID# 160957
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Clinical Inquest Center Ltd /ID# 160892
Beavercreek, Ohio, United States, 45431-2573
CTI Clinical Research Center /ID# 160942
Cincinnati, Ohio, United States, 45212
Univ Hosp Cleveland /ID# 160953
Cleveland, Ohio, United States, 44106
Central Ohio Clinical Research /ID# 201162
Columbus, Ohio, United States, 43213-3399
Duplicate_Optimed Research /ID# 165600
Columbus, Ohio, United States, 43235
Hilltop Obstetrics & Gynecology /ID# 203576
Middletown, Ohio, United States, 45005-5200
University of Toledo /ID# 160923
Toledo, Ohio, United States, 43614
United States, Oregon
Oregon Health and Science University /ID# 161514
Portland, Oregon, United States, 97239
United States, Pennsylvania
OB/GYN Associates of Erie /ID# 161541
Erie, Pennsylvania, United States, 16507-1423
Penn State University and Milton S. Hershey Medical Center /ID# 160896
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania /ID# 160936
Philadelphia, Pennsylvania, United States, 19104-5502
DUP_Thomas Jefferson University /ID# 200304
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Vista Clinical Research /ID# 160946
Columbia, South Carolina, United States, 29201
VitaLink Research-Spartanburg /ID# 164592
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Chattanooga Medical Research /ID# 160885
Chattanooga, Tennessee, United States, 37404
WR-ClinSearch /ID# 160887
Chattanooga, Tennessee, United States, 37421-1605
The Jackson Clinic, PA /ID# 162496
Jackson, Tennessee, United States, 38305
Research Memphis Associates, LLC /ID# 160939
Memphis, Tennessee, United States, 38119-3895
United States, Texas
OBGYN North /ID# 203580
Austin, Texas, United States, 78758-5444
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
Austin, Texas, United States, 78758-5653
Discovery Clinical Trials -HCWC /ID# 161543
Dallas, Texas, United States, 75230-2571
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
Dallas, Texas, United States, 75390-8575
Baylor Scott & White /ID# 161515
Fort Worth, Texas, United States, 76104-4110
Willowbend Health and Wellness - Frisco /ID# 160954
Frisco, Texas, United States, 75035
Advances in Health, Inc. /ID# 160930
Houston, Texas, United States, 77030
The Ob/Gyn Center /ID# 165928
Houston, Texas, United States, 77030
Precision Research Institute, LLC /ID# 161554
Houston, Texas, United States, 77036
The Woman's Hospital of Texas /ID# 160959
Houston, Texas, United States, 77054
Centex Studies, Inc /ID# 163858
Houston, Texas, United States, 77058-2705
Centex Studies, Inc. - Houston /ID# 160917
Houston, Texas, United States, 77058
UAG Innovation Women Research, /ID# 167415
Houston, Texas, United States, 77074
America's Adv. Wellness Center /ID# 167548
Houston, Texas, United States, 77080
FMC Science /ID# 160886
Lampasas, Texas, United States, 76550
ClinRx Research, LLC /ID# 201170
Plano, Texas, United States, 75024-5280
Clinical Trials of Texas, Inc /ID# 161510
San Antonio, Texas, United States, 78229
VIP Trials /ID# 161546
San Antonio, Texas, United States, 78230
Houston Ctr for Clin Research /ID# 160837
Sugar Land, Texas, United States, 77479
The Univ Texas HSC at Tyler /ID# 161533
Tyler, Texas, United States, 75708
Center of Reproductive Medicine /ID# 162498
Webster, Texas, United States, 77598
United States, Virginia
Univ of Virgnia Medical center /ID# 166283
Charlottesville, Virginia, United States, 22908-0816
Eastern Virginia Med School /ID# 160856
Norfolk, Virginia, United States, 23507-1627
Clinical Research Partners /ID# 160929
North Chesterfield, Virginia, United States, 23235
Clinical Research Partners /ID# 160948
North Chesterfield, Virginia, United States, 23235
Clinical Trials Virginia, Inc. /ID# 160943
Richmond, Virginia, United States, 23225
Specialists for Women /ID# 201129
Suffolk, Virginia, United States, 23434-8151
Tidewater Clinical Research /ID# 160949
Virginia Beach, Virginia, United States, 23456
Puerto Rico
Henry A. Rodriguez Ginorio, MD /ID# 160861
San Juan, Puerto Rico, 00917-5022
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03271489    
Other Study ID Numbers: M16-283
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Elagolix Sodium
Elagolix + Norethindrone Acetate
Elagolix + E2/NETA
Heavy Menstrual Bleeding (HMB)
Heavy Uterine Bleeding
Additional relevant MeSH terms:
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Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances