Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
NCT ID: NCT02691494
Last Updated: 2021-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2016-02-03
2019-01-23
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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Placebo
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)
Placebo for Estradiol/Norethindrone Acetate
Placebo capsules
Placebo for Elagolix
Film-coated placebo tablets
Elagolix
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix
Film-coated tablets
Placebo for Estradiol/Norethindrone Acetate
Placebo capsules
Elagolix + E2/NETA
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix
Film-coated tablets
Estradiol/Norethindrone Acetate
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
Interventions
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Elagolix
Film-coated tablets
Placebo for Estradiol/Norethindrone Acetate
Placebo capsules
Estradiol/Norethindrone Acetate
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
Placebo for Elagolix
Film-coated placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
* Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
* Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.
Exclusion Criteria
* Subject has history of osteoporosis or other metabolic bone disease.
* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Subject 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 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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Alabama Clinical Therapeutics, LLC /ID# 152258
Birmingham, Alabama, United States
Choice Research, LLC /ID# 150988
Dothan, Alabama, United States
Brown, Pearson, Guepet Gynecology /ID# 151020
Fairhope, Alabama, United States
Mobile, Ob-Gyn, P.C. /ID# 144294
Mobile, Alabama, United States
Mesa Obstetricians and Gynecol /ID# 149139
Mesa, Arizona, United States
Visions Clinical Research-Tucs /ID# 151017
Tucson, Arizona, United States
Core Healthcare Group /ID# 151016
Cerritos, California, United States
Diagnamics Inc. /ID# 152469
Encinitas, California, United States
HCP Clinical Research LLC /ID# 154434
Huntington Beach, California, United States
Alliance Research Centers /ID# 149752
Laguna Hills, California, United States
University of California, Los Angeles /ID# 149760
Los Angeles, California, United States
Futura Research, Inc. /ID# 149759
Norwalk, California, United States
Farid Yasharpour MD Medical Co /ID# 149770
San Fernando, California, United States
Clinical Trial Investigators /ID# 152470
Tustin, California, United States
Bayview Research Group LLC /ID# 153799
Valley Village, California, United States
Emerson Clinical Research Inst /ID# 152348
Washington D.C., District of Columbia, United States
Ideal Clinical Research Inc. /ID# 149757
Aventura, Florida, United States
Seffner Premier Health Care, P /ID# 167480
Brandon, Florida, United States
Olympian Clinical Research /ID# 149756
Clearwater, Florida, United States
KO Clinical Research, LLC /ID# 144299
Fort Lauderdale, Florida, United States
University of Florida /ID# 149751
Gainesville, Florida, United States
Solutions Through Adv Rch /ID# 151021
Jacksonville, Florida, United States
Meridien Research /ID# 167100
Kenneth City, Florida, United States
Invictus Clinical Research Group,LLC /ID# 141859
Miami, Florida, United States
Precision Research Org, LLC /ID# 144335
Miami Lakes, Florida, United States
Suncoast Clinical Research /ID# 149765
New Port Richey, Florida, United States
All Wmns HC of West Broward /ID# 144298
Plantation, Florida, United States
Oncova Clinical Research, Inc. /ID# 149764
Saint Cloud, Florida, United States
Physician Care Clin. Res., LLC /ID# 149766
Sarasota, Florida, United States
Qps-Mra, Llc /Id# 144325
South Miami, Florida, United States
Martin Health System Center /ID# 152263
Stuart, Florida, United States
University of South Florida /ID# 149754
Tampa, Florida, United States
Axcess Medical Research /ID# 149769
Wellington, Florida, United States
Virtus Research Consultant,LLC /ID# 144296
Wellington, Florida, United States
Paramount Research Solutions /ID# 149291
Alpharetta, Georgia, United States
Agile Clinical Research Trials /ID# 167074
Atlanta, Georgia, United States
Mount Vernon Clinical Res, LLC /ID# 144297
Atlanta, Georgia, United States
Atlanta Women's Research Inst /ID# 144303
Atlanta, Georgia, United States
Masters of Clinical Research, Inc. /ID# 167400
Augusta, Georgia, United States
Georgia Regents University /ID# 144295
Augusta, Georgia, United States
Meridian Clinical Research, LLC /ID# 149144
Savannah, Georgia, United States
Gyn-Care, Inc. /ID# 149341
Smyrna, Georgia, United States
Atlanta Gynecology Research Institute /ID# 151014
Suwanee, Georgia, United States
Womens Healthcare Assoc, DBA /ID# 149762
Idaho Falls, Idaho, United States
Advanced Clinical Research /ID# 149767
Meridian, Idaho, United States
University of Chicago /ID# 152257
Chicago, Illinois, United States
Affinity Clinical Research /ID# 167119
Oak Brook, Illinois, United States
Center for Women's Research, Inc /ID# 144300
Palos Heights, Illinois, United States
Women's Health Advantage /ID# 144301
Fort Wayne, Indiana, United States
The Iowa Clinic /ID# 150105
West Des Moines, Iowa, United States
PRN Professional Research Network of Kansas, LLC /ID# 152265
Wichita, Kansas, United States
Bluegrass Clinical Research /ID# 150103
Louisville, Kentucky, United States
Clinical Trials Management, LLC - Covington /ID# 144314
Covington, Louisiana, United States
Women Under Study, LLC /ID# 144312
New Orleans, Louisiana, United States
Baltimore Suburban Health /ID# 154638
Baltimore, Maryland, United States
Womens Health Center /ID# 154209
Glen Burnie, Maryland, United States
Maryland Ctr for Sexual Health /ID# 149778
Lutherville, Maryland, United States
NECCR Fall River LLC /ID# 149584
Fall River, Massachusetts, United States
Saginaw Valley Med Res Group /ID# 149768
Saginaw, Michigan, United States
Accent Clinical Trials /ID# 149753
Las Vegas, Nevada, United States
Jersey Shore University Medical Center /ID# 149779
Neptune City, New Jersey, United States
Rowan University SOM /ID# 152697
Stratford, New Jersey, United States
SUNY Downstate Medical Center /ID# 144311
Brooklyn, New York, United States
Manhattan Medical Research /ID# 167077
New York, New York, United States
Weill Cornell Medicine /ID# 149585
New York, New York, United States
Montefiore Medical Center /ID# 149582
The Bronx, New York, United States
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
Fayetteville, North Carolina, United States
Unified Women's Clinical Research-Greensboro /ID# 149588
Greensboro, North Carolina, United States
Pinewest Ob-Gyn, Inc. /ID# 145671
High Point, North Carolina, United States
Eastern Carolina Women's Centr /ID# 144309
New Bern, North Carolina, United States
Wake Research Associates, LLC /ID# 144307
Raleigh, North Carolina, United States
Clinical Inquest Center Ltd /ID# 148728
Beavercreek, Ohio, United States
CTI Clinical Research Center /ID# 149761
Cincinnati, Ohio, United States
The Christ Hospital /ID# 150104
Cincinnati, Ohio, United States
Alpha Research Associates LLC /ID# 152471
Dayton, Ohio, United States
Comprehensive Womens Care /ID# 144306
Westerville, Ohio, United States
Family Medical Associates /ID# 145668
Levittown, Pennsylvania, United States
University of Pennsylvania /ID# 149586
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia, LLC /ID# 151015
Philadelphia, Pennsylvania, United States
Reading Hosp Clncl Trials Ofc /ID# 149583
West Reading, Pennsylvania, United States
Holston Medical Group /ID# 149763
Bristol, Tennessee, United States
Chattanooga Medical Research /ID# 145667
Chattanooga, Tennessee, United States
Chattanooga Women for Women /ID# 167051
Hixson, Tennessee, United States
The Jackson Clinic, PA /ID# 145670
Jackson, Tennessee, United States
The Womens Physician Group /ID# 144317
Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 167333
Nashville, Tennessee, United States
Lotus Gynecology /ID# 149140
Austin, Texas, United States
Inquest Clinical Research /ID# 149755
Baytown, Texas, United States
Texas Health Presbyterian Hosp /ID# 149142
Dallas, Texas, United States
Baylor College of Medicine /ID# 149141
Houston, Texas, United States
The Woman's Hospital of Texas /ID# 144319
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 150106
Houston, Texas, United States
BI Research Center /ID# 149143
Houston, Texas, United States
FMC Science /ID# 151802
Lampasas, Texas, United States
Willowbend Health and Wellness /ID# 144318
Plano, Texas, United States
Clinical Trials of Texas,Inc. /ID# 144322
San Antonio, Texas, United States
Center of Reproductive Medicin /ID# 167235
Webster, Texas, United States
Southampton Women's Health /ID# 152325
Franklin, Virginia, United States
Tidewater Physicians for Women /ID# 144321
Norfolk, Virginia, United States
Clinical Research Partners, LLC /ID# 144310
Richmond, Virginia, United States
Alliance Womens Health /ID# 152468
Richmond, Virginia, United States
Zain Research /ID# 151018
Richland, Washington, United States
Virginia Mason Medical Center /ID# 149758
Seattle, Washington, United States
Medicor Research Inc. /ID# 153406
Greater Sudbury, Ontario, Canada
Victory Reproductive Care /ID# 150247
Windsor, Ontario, Canada
Countries
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References
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Simon JA, Stewart EA, Jewell S, Li M, Snabes MC. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials. F S Rep. 2024 Jun 14;5(3):285-295. doi: 10.1016/j.xfre.2024.06.002. eCollection 2024 Sep.
Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.
Stewart EA, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg EC, Gillispie-Bell V, Imudia AN, Liu R, Kim JH, Al-Hendy A. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids. J Womens Health (Larchmt). 2022 May;31(5):698-705. doi: 10.1089/jwh.2021.0152. Epub 2021 Sep 28.
Muneyyirci-Delale O, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg E, Gillispie V, Hurtado S, Kim JH, Wang A, Wang H, Stewart EA. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep. 2021 May 26;2(3):338-346. doi: 10.1016/j.xfre.2021.05.004. eCollection 2021 Sep.
Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.
Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M12-817
Identifier Type: -
Identifier Source: org_study_id
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