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
NCT ID: NCT02654054
Last Updated: 2020-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
413 participants
INTERVENTIONAL
2015-12-22
2018-12-12
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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Summers, Birmingham, AL /ID# 139684
Birmingham, Alabama, United States
University of South Alabama /ID# 148763
Mobile, Alabama, United States
WCCT Global, LLC /ID# 145666
Costa Mesa, California, United States
American Clinical Trials /ID# 147374
Hawaiian Gardens, California, United States
Grossmont Ctr Clin Research /ID# 144011
La Mesa, California, United States
Long Beach Clinical Trial Serv /ID# 152424
Long Beach, California, United States
National Research Institute /ID# 151629
Los Angeles, California, United States
University of California, Los Angeles /ID# 144107
Los Angeles, California, United States
Beach OBGYN Medical Group /ID# 151414
Newport Beach, California, United States
Advanced RX Clinical Research /ID# 149168
Westminster, California, United States
Bluebird Clinical Trials, LLC /ID# 144843
Colorado Springs, Colorado, United States
Advanced Women's Health Institution /ID# 144108
Greenwood Village, Colorado, United States
Medstar Health Research Institute /ID# 145933
Washington D.C., District of Columbia, United States
James A. Simon, MD, PC /ID# 139675
Washington D.C., District of Columbia, United States
Helix Biomedics, LLC /ID# 147114
Boynton Beach, Florida, United States
Brandon Premier Health Care, PA /ID# 153130
Brandon, Florida, United States
Florida Clin Res Group /ID# 139811
Ckearwater, Florida, United States
Universal Clinical Research A /ID# 139742
Doral, Florida, United States
Clinical Physiology Associates /ID# 139736
Fort Myers, Florida, United States
Meridien Research /ID# 139663
Kenneth City, Florida, United States
Altus Research, Inc /ID# 139662
Lake Worth, Florida, United States
South Florida Wellness & Clinic /ID# 143558
Margate, Florida, United States
LCC Medical Research Institute /ID# 143551
Miami, Florida, United States
Healthcare Clinical Data, Inc /ID# 139650
Miami, Florida, United States
Ocean Blue Med Research Ctr /ID# 139826
Miami, Florida, United States
Salom Tangir, LLC /ID# 151732
Miramar, Florida, United States
Advanced Research Institute /ID# 143554
New Port Richey, Florida, United States
Clinical Associates of Orlando /ID# 148123
Orlando, Florida, United States
Omega Research Consultants /ID# 139648
Orlando, Florida, United States
Unified Womens Clin Research /ID# 145169
Panama City, Florida, United States
Comprehensive Clinical Trials /ID# 139644
West Palm Beach, Florida, United States
Atlanta Medical Research Insti /ID# 147117
Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 139645
Alpharetta, Georgia, United States
Agile Clinical Research Trials /ID# 143563
Atlanta, Georgia, United States
Perimeter Inst Clinical Resear /ID# 148298
Atlanta, Georgia, United States
Masters of Clinical Research, Inc. /ID# 139658
Augusta, Georgia, United States
Fellows Research Alliance, Inc /ID# 139655
Savannah, Georgia, United States
Boise Family Medical Center /ID# 139844
Boise, Idaho, United States
Women's Health Practice, LLC /ID# 143569
Champaign, Illinois, United States
Great Lakes Clinical Trials /ID# 148135
Chicago, Illinois, United States
Affinity Clinical Research /ID# 150980
Oak Brook, Illinois, United States
American Health Network of IN /ID# 139822
Avon, Indiana, United States
GTC Research /ID# 141854
Kansas City, Kansas, United States
Cypress Medical Research Ctr /ID# 147116
Wichita, Kansas, United States
Research Integrity, LLC /ID# 139727
Owensboro, Kentucky, United States
Clinical Trials Management, LLC - Covington /ID# 139651
Covington, Louisiana, United States
Ochsner Baptist Medical Center /ID# 139740
New Orleans, Louisiana, United States
Omni Fertility and Laser Insti /ID# 139836
Shreveport, Louisiana, United States
Capital Women's Care /ID# 144109
Frederick, Maryland, United States
Genesis Clinical Research - Fall River /ID# 148449
Fall River, Massachusetts, United States
Great Lakes Research Group,Inc /ID# 139659
Bay City, Michigan, United States
Grand Rapids Womens Health /ID# 139705
Grand Rapids, Michigan, United States
Wayne State University Physician Group - Southfield /ID# 139802
Southfield, Michigan, United States
Office of Edmond E. Pack, MD /ID# 139792
Las Vegas, Nevada, United States
Mabey, Las Vegas, NV /ID# 148138
Las Vegas, Nevada, United States
Lawrence OB/GYN /ID# 143567
Lawrenceville, New Jersey, United States
Bosque Women's Care /ID# 145934
Albuquerque, New Mexico, United States
Manhattan Medical Research /ID# 144471
New York, New York, United States
Cwrwc /Id# 139664
Durham, North Carolina, United States
Unified Women's Clinical Research-Greensboro /ID# 139829
Greensboro, North Carolina, United States
Unified Women's Clinical Resea /ID# 139774
Raleigh, North Carolina, United States
PMG Research of Wilmington LLC /ID# 152563
Wilmington, North Carolina, United States
Unified Women's Clinical Resea /ID# 144721
Winston-Salem, North Carolina, United States
University of Cincinnati /ID# 139820
Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 139741
Cleveland, Ohio, United States
Complete Healthcare for Women /ID# 139673
Columbus, Ohio, United States
Miami Valley Hospital /ID# 144430
Dayton, Ohio, United States
University of Toledo /ID# 139787
Toledo, Ohio, United States
Legacy Medical Group-Portland /ID# 148807
Portland, Oregon, United States
Main Line Fertility Center /ID# 150295
Bryn Mawr, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 139733
Hershey, Pennsylvania, United States
Thomas Jefferson University /ID# 139812
Philadelphia, Pennsylvania, United States
Temple University Hospital /ID# 151429
Philadelphia, Pennsylvania, United States
Clinical Trials Research Svcs /ID# 139707
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina /ID# 148754
Charleston, South Carolina, United States
Vista Clinical Research /ID# 139797
Columbia, South Carolina, United States
WR-ClinSearch /ID# 143538
Chattanooga, Tennessee, United States
Research Memphis Associates, LLC /ID# 139674
Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 139730
Nashville, Tennessee, United States
UT Southwestern Medical Center /ID# 143537
Dallas, Texas, United States
Advances in Health, Inc. /ID# 139672
Houston, Texas, United States
Victorium Clinical Research /ID# 149630
San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 139776
San Antonio, Texas, United States
Houston Ctr for Clin Research /ID# 149149
Sugar Land, Texas, United States
Center of Reproductive Medicin /ID# 139813
Webster, Texas, United States
Eastern Virginia Med School /ID# 139647
Norfolk, Virginia, United States
Clinical Research Partners, LL /ID# 143999
North Chesterfield, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 139801
Richmond, Virginia, United States
Emerson Clinical Research /ID# 147373
Vienna, Virginia, United States
Seattle Women's Health, Research, Gynecology /ID# 139768
Seattle, Washington, United States
Premier Clinical Research /ID# 148145
Spokane, Washington, United States
Froedtert and Medical College /ID# 143566
Milwaukee, Wisconsin, United States
IWK Health Center /ID# 149066
Halifax, Nova Scotia, Canada
The Ottawa Hospital /ID# 148695
Ottawa, Ontario, Canada
Rodriguez-Ginorio, San Juan /ID# 139847
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848
San Juan, , Puerto Rico
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.
Al-Hendy A, Bradley L, Owens CD, Wang H, Barnhart KT, Feinberg E, Schlaff WD, Puscheck EE, Wang A, Gillispie V, Hurtado S, Muneyyirci-Delale O, Archer DF, Carr BR, Simon JA, Stewart EA. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20.
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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M12-815
Identifier Type: -
Identifier Source: org_study_id
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