An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT02925494
Last Updated: 2021-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
433 participants
INTERVENTIONAL
2016-09-14
2019-03-22
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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Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
Estradiol/Norethindrone Acetate
capsules
Elagolix
film-coated 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
Interventions
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Estradiol/Norethindrone Acetate
capsules
Elagolix
film-coated tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
* Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
* Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
Exclusion Criteria
* Participant is planning a pregnancy within the next 18 months.
* Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
* Participant has any new medical conditions that may be unsuitable for participation.
* Participant is using any systemic corticosteroids for over 14 days 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# 153217
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 153336
Birmingham, Alabama, United States
Choice Research, LLC /ID# 153492
Dothan, Alabama, United States
Brown, Pearson, Guepet Gynecology /ID# 153278
Fairhope, Alabama, United States
University of South Alabama /ID# 153415
Mobile, Alabama, United States
Mobile, Ob-Gyn, P.C. /ID# 153442
Mobile, Alabama, United States
Mesa Obstetricians and Gynecol /ID# 153269
Mesa, Arizona, United States
Core Healthcare Group /ID# 153282
Cerritos, California, United States
Diagnamics Inc. /ID# 153347
Encinitas, California, United States
Grossmont Ctr Clin Research /ID# 153324
La Mesa, California, United States
Futura Research, Inc. /ID# 153345
Norwalk, California, United States
Farid Yasharpour MD Medical Co /ID# 153482
San Fernando, California, United States
Advanced Women's Health Institution /ID# 153401
Greenwood Village, Colorado, United States
Medstar Health Research Institute /ID# 153321
Washington D.C., District of Columbia, United States
Emerson Clinical Research Inst /ID# 162755
Washington D.C., District of Columbia, United States
James A. Simon, MD, PC /ID# 153323
Washington D.C., District of Columbia, United States
Helix Biomedics, LLC /ID# 153440
Boynton Beach, Florida, United States
Brandon Premier Health Care, PA /ID# 165791
Brandon, Florida, United States
Florida Fertility Institute /ID# 153308
Clearwater, Florida, United States
Omega Research Consultants, LLC /ID# 153381
DeBary, Florida, United States
KO Clinical Research, LLC /ID# 153198
Fort Lauderdale, Florida, United States
Clinical Physiology Assoc. /ID# 153444
Fort Myers, Florida, United States
Solutions Through Adv Rch /ID# 153283
Jacksonville, Florida, United States
Meridien Research /ID# 153310
Kenneth City, Florida, United States
Altus Research, Inc /ID# 153307
Lake Worth, Florida, United States
South Florida Wellness & Clinic /ID# 153420
Margate, Florida, United States
LCC Medical Research Institute /ID# 153296
Miami, Florida, United States
Invictus Clinical Research Group,LLC /ID# 153196
Miami, Florida, United States
Healthcare Clinical Data, Inc /ID# 153425
Miami, Florida, United States
Ocean Blue Med Research Ctr /ID# 153225
Miami, Florida, United States
Precision Research Org, LLC /ID# 153276
Miami Lakes, Florida, United States
Suncoast Clinical Research /ID# 153206
New Port Richey, Florida, United States
Advanced Research Institute /ID# 153413
New Port Richey, Florida, United States
Clinical Associates of Orlando /ID# 153427
Orlando, Florida, United States
Unified Womens Clin Research /ID# 153229
Panama City, Florida, United States
All Wmns HC of West Broward /ID# 153434
Plantation, Florida, United States
Oncova Clinical Research, Inc. /ID# 153497
Saint Cloud, Florida, United States
Physician Care Clin. Res., LLC /ID# 153210
Sarasota, Florida, United States
Qps-Mra, Llc /Id# 153456
South Miami, Florida, United States
University of South Florida /ID# 153271
Tampa, Florida, United States
Axcess Medical Research /ID# 153500
Wellington, Florida, United States
Virtus Research Consultant,LLC /ID# 153398
Wellington, Florida, United States
Comprehensive Clinical Trials /ID# 153350
West Palm Beach, Florida, United States
Atlanta Medical Research Insti /ID# 153298
Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 153424
Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 160974
Alpharetta, Georgia, United States
Mount Vernon Clinical Res, LLC /ID# 153403
Atlanta, Georgia, United States
Atlanta Women's Research Inst /ID# 153212
Atlanta, Georgia, United States
Masters of Clinical Research, Inc. /ID# 153295
Augusta, Georgia, United States
Paramount Research Solutions /ID# 153351
College Park, Georgia, United States
Fellows Research Alliance, Inc /ID# 153227
Savannah, Georgia, United States
Clinical Research Consultants of Atlanta /ID# 153285
Suwanee, Georgia, United States
Atlanta Gynecology Research Institute /ID# 200074
Suwanee, Georgia, United States
Sonora Clinical Research /ID# 153231
Meridian, Idaho, United States
Affinity Clinical Research /ID# 153417
Oak Brook, Illinois, United States
Bluegrass Clinical Research /ID# 153280
Louisville, Kentucky, United States
Clinical Trials Management, LLC - Covington /ID# 153211
Covington, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 153439
Covington, Louisiana, United States
Ochsner Baptist Medical Center /ID# 153459
New Orleans, Louisiana, United States
Omni Fertility and Laser Insti /ID# 153228
Shreveport, Louisiana, United States
Baltimore Suburban Health /ID# 168386
Baltimore, Maryland, United States
NECCR Fall River LLC /ID# 153274
Fall River, Massachusetts, United States
Genesis Clinical Research /ID# 153379
Fall River, Massachusetts, United States
Great Lakes Research Group,Inc /ID# 153302
Bay City, Michigan, United States
Saginaw Valley Med Res Group /ID# 153498
Saginaw, Michigan, United States
Wayne State University Physician Group - Southfield /ID# 153418
Southfield, Michigan, United States
Accent Clinical Trials /ID# 153474
Las Vegas, Nevada, United States
Office of Edmond E. Pack, MD /ID# 153411
Las Vegas, Nevada, United States
Mabey, Las Vegas, NV /ID# 153314
Las Vegas, Nevada, United States
Lawrence OB/GYN /ID# 153218
Lawrenceville, New Jersey, United States
Jersey Shore University Medical Center /ID# 153495
Neptune City, New Jersey, United States
Bosque Women's Care /ID# 153223
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 153344
Brooklyn, New York, United States
Manhattan Medical Research /ID# 153386
New York, New York, United States
Weill Cornell Medicine /ID# 153275
New York, New York, United States
Cwrwc /Id# 153313
Durham, North Carolina, United States
Unified Women's Clinical Research-Greensboro /ID# 153499
Greensboro, North Carolina, United States
Pinewest Ob-Gyn, Inc. /ID# 153197
High Point, North Carolina, United States
Eastern Carolina Women's Centr /ID# 153341
New Bern, North Carolina, United States
Unified Women's Clinical Resea /ID# 153312
Raleigh, North Carolina, United States
Wake Research Associates, LLC /ID# 153402
Raleigh, North Carolina, United States
Unified Women's Clinical Resea /ID# 153297
Winston-Salem, North Carolina, United States
Clinical Inquest Center Ltd /ID# 153436
Beavercreek, Ohio, United States
CTI Clinical Research Center /ID# 153201
Cincinnati, Ohio, United States
University Hospitals Cleveland /ID# 153450
Cleveland, Ohio, United States
University of Toledo /ID# 153409
Toledo, Ohio, United States
Comprehensive Womens Care /ID# 153396
Westerville, Ohio, United States
Legacy Medical Group-Portland /ID# 168286
Portland, Oregon, United States
Main Line Fertility Center /ID# 153410
Bryn Mawr, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 153443
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 153203
Philadelphia, Pennsylvania, United States
Thomas Jefferson University /ID# 153319
Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia, LLC /ID# 153279
Philadelphia, Pennsylvania, United States
Reading Hosp Clncl Trials Ofc /ID# 153475
West Reading, Pennsylvania, United States
Medical University of South Carolina /ID# 153325
Charleston, South Carolina, United States
Vista Clinical Research /ID# 153399
Columbia, South Carolina, United States
Chattanooga Medical Research /ID# 153405
Chattanooga, Tennessee, United States
WR-ClinSearch /ID# 153404
Chattanooga, Tennessee, United States
Research Memphis Associates, LLC /ID# 153322
Memphis, Tennessee, United States
Women's Health Trials /ID# 153426
Menphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 153441
Nashville, Tennessee, United States
Lotus Gynecology /ID# 153476
Austin, Texas, United States
Texas Health Presbyterian Hosp /ID# 153339
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 153400
Dallas, Texas, United States
Baylor Scott & White /ID# 153273
Fort Worth, Texas, United States
Willowbend Health and Wellness /ID# 153458
Frisco, Texas, United States
Advances in Health, Inc. /ID# 153414
Houston, Texas, United States
The Woman's Hospital of Texas /ID# 153270
Houston, Texas, United States
FMC Science /ID# 153289
Lampasas, Texas, United States
Clinical Trials of Texas,Inc. /ID# 153209
San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 153315
San Antonio, Texas, United States
Houston Ctr for Clin Research /ID# 153221
Sugar Land, Texas, United States
Center of Reproductive Medicin /ID# 153320
Webster, Texas, United States
Tidewater Physicians for Women /ID# 153432
Norfolk, Virginia, United States
Eastern Virginia Med School /ID# 153380
Norfolk, Virginia, United States
Clinical Research Partners, LL /ID# 153412
North Chesterfield, Virginia, United States
Clinical Research Partners, LLC /ID# 153343
Richmond, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 153419
Richmond, Virginia, United States
Emerson Clinical Research Inst /ID# 153416
Vienna, Virginia, United States
Virginia Mason Medical Center /ID# 153342
Seattle, Washington, United States
Seattle Women's Health, Research, Gynecology /ID# 153306
Seattle, Washington, United States
Victory Reproductive Care /ID# 153299
Windsor, Ontario, Canada
Rodriguez-Ginorio, San Juan /ID# 153328
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
San Juan, , Puerto Rico
Countries
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References
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Simon JA, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Dayspring T, Feinberg EC, Gillispie V, Hurtado S, Kim J, Liu R, Owens CD, Muneyyirci-Delale O, Wang A, Watts NB, Schlaff WD. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020 Jun;135(6):1313-1326. doi: 10.1097/AOG.0000000000003869.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M12-816
Identifier Type: -
Identifier Source: org_study_id
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