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

Last updated: June 9, 2020
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Hemorrhage

Uterine Fibroids

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02654054
M12-815
  • Ages 18-51
  • Female

Study Summary

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is a premenopausal female at the time of Screening.

  • 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 bymenstrual blood loss > 80 mL during each of two screening menses as measured by thealkaline hematin method.

  • Subject has negative urine and/or serum pregnancy test in Screening and just prior tofirst dose.

  • Subject has an adequate endometrial biopsy performed during Screening, the results ofwhich show no clinically significant endometrial pathology.

Exclusion

Exclusion Criteria:

  • Subject has screening pelvic ultrasound or saline infusion sonohysterography resultsthat show a clinically significant gynecological disorder.

  • Subject has history of osteoporosis or other metabolic bone disease.

  • Subject has clinically significant abnormalities in clinical chemistry, hematology, orurinalysis.

  • 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 anytime (e.g., schizophrenia, bipolar disorder).

  • Subject is using any systemic corticosteroids for over 14 days within 3 months priorto Screening or is likely to require treatment with systemic corticosteroids duringthe course of the study. Over the counter and prescription topical, inhaled,intranasal or injectable (for occasional use) corticosteroids are allowed.

Study Design

Total Participants: 413
Study Start date:
December 22, 2015
Estimated Completion Date:
December 12, 2018

Connect with a study center

  • IWK Health Center /ID# 149066

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • The Ottawa Hospital /ID# 148695

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Ponce Medical School Foundation Inc. /ID# 151735

    Ponce, 00717
    Puerto Rico

    Site Not Available

  • University of Puerto Rico, School of Medicine /ID# 139848

    Rio Piedas, 00935
    Puerto Rico

    Site Not Available

  • University of Puerto Rico, School of Medicine /ID# 139848

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Rodriguez-Ginorio, San Juan /ID# 139847

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Summers, Birmingham, AL /ID# 139684

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • University of South Alabama /ID# 148763

    Mobile, Alabama 36604-3302
    United States

    Site Not Available

  • Mesa Obstetricians and Gynecologists /ID# 147115

    Mesa, Arizona 85209
    United States

    Site Not Available

  • MomDoc Womens Health Research /ID# 151656

    Phoenix, Arizona 85251
    United States

    Site Not Available

  • Reliance Institute of Clinical Research /ID# 139729

    Chino, California 91710
    United States

    Site Not Available

  • WCCT Global, LLC /ID# 145666

    Costa Mesa, California 92626
    United States

    Site Not Available

  • American Clinical Trials /ID# 147374

    Hawaiian Gardens, California 90716
    United States

    Site Not Available

  • Grossmont Ctr Clin Research /ID# 144011

    La Mesa, California 91942
    United States

    Site Not Available

  • Long Beach Clinical Trial Serv /ID# 152424

    Long Beach, California 90806
    United States

    Site Not Available

  • National Research Institute /ID# 151629

    Los Angeles, California 90057
    United States

    Site Not Available

  • University of California, Los Angeles /ID# 144107

    Los Angeles, California 90095
    United States

    Site Not Available

  • Beach OBGYN Medical Group /ID# 151414

    Newport Beach, California 92663-3657
    United States

    Site Not Available

  • University of California, Los Angeles /ID# 144107

    Santa Monica, California 90404
    United States

    Site Not Available

  • Harbor-UCLA Medical Center And Labiomed Research Institute /ID# 144107

    Torrance, California 90502
    United States

    Site Not Available

  • Advanced RX Clinical Research /ID# 149168

    Westminster, California 92683-4567
    United States

    Site Not Available

  • Bluebird Clinical Trials, LLC /ID# 144843

    Colorado Springs, Colorado 80923
    United States

    Site Not Available

  • Advanced Women's Health Instit /ID# 144108

    Denver, Colorado 80246
    United States

    Site Not Available

  • Advanced Women's Health Institution /ID# 144108

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • James A. Simon, MD, PC /ID# 139675

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Medstar Health Research Institute /ID# 145933

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center /ID# 145933

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Helix Biomedics, LLC /ID# 147114

    Boynton Beach, Florida 33436-6634
    United States

    Site Not Available

  • Brandon Premier Health Care, PA /ID# 153130

    Brandon, Florida 33510-3107
    United States

    Site Not Available

  • Florida Clin Res Group /ID# 139811

    Ckearwater, Florida 33759
    United States

    Site Not Available

  • Florida Clin Res Group /ID# 139811

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Omega Research Consultants, LLC /ID# 139648

    Debary, Florida 32713
    United States

    Site Not Available

  • Universal Clinical Research A /ID# 139742

    Doral, Florida 33166
    United States

    Site Not Available

  • Clinical Physiology Associates /ID# 139736

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Meridien Research /ID# 139663

    Kenneth City, Florida 33709-3113
    United States

    Site Not Available

  • Altus Research, Inc /ID# 139662

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • South Florida Wellness & Clinic /ID# 143558

    Margate, Florida 33063
    United States

    Site Not Available

  • Healthcare Clinical Data, Inc /ID# 139650

    Miami, Florida 33161
    United States

    Site Not Available

  • LCC Medical Research Institute /ID# 143551

    Miami, Florida 33126
    United States

    Site Not Available

  • Ocean Blue Med Research Ctr /ID# 139826

    Miami, Florida 33166
    United States

    Site Not Available

  • Ocean Blue Medical Research Center, Inc. /ID# 139826

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Salom Tangir, LLC /ID# 151732

    Miramar, Florida 33027
    United States

    Site Not Available

  • Advanced Research Institute /ID# 143554

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Healthcare Clinical Data, Inc. /ID# 139650

    North Miami, Florida 33161
    United States

    Site Not Available

  • Clinical Associates of Orlando /ID# 148123

    Orlando, Florida 32806
    United States

    Site Not Available

  • Omega Research Consultants /ID# 139648

    Orlando, Florida 32810
    United States

    Site Not Available

  • Unified Womens Clin Research /ID# 145169

    Panama City, Florida 32045
    United States

    Site Not Available

  • Meridien Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Meridien Research /ID# 139663

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Comprehensive Clinical Trials /ID# 139644

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Atlanta Medical Research Insti /ID# 147117

    Alpharetta, Georgia 30005-4419
    United States

    Site Not Available

  • Paramount Research Solutions /ID# 139645

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Agile Clinical Research Trials /ID# 143563

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Perimeter Inst Clinical Resear /ID# 148298

    Atlanta, Georgia 30338
    United States

    Site Not Available

  • Masters of Clinical Research, Inc. /ID# 139658

    Augusta, Georgia 30909
    United States

    Site Not Available

  • GYN-CARE/ Paramount Research Solutions /ID# 139645

    College Park, Georgia 30349
    United States

    Site Not Available

  • Fellows Research Alliance, Inc /ID# 139655

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Boise Family Medical Center /ID# 139844

    Boise, Idaho 83709
    United States

    Site Not Available

  • Women's Health Practice, LLC /ID# 143569

    Champaign, Illinois 61820
    United States

    Site Not Available

  • Great Lakes Clinical Trials /ID# 148135

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Affinity Clinical Research /ID# 150980

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • American Health Network of IN /ID# 139822

    Avon, Indiana 46123
    United States

    Site Not Available

  • GTC Research /ID# 141854

    Kansas City, Kansas 66218
    United States

    Site Not Available

  • GTC Research /ID# 141854

    Shawnee, Kansas 66218
    United States

    Site Not Available

  • GTC Research /ID# 141854

    Shawnee Mission, Kansas 66218
    United States

    Site Not Available

  • Cypress Medical Research Ctr /ID# 147116

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Research Integrity, LLC /ID# 139727

    Owensboro, Kentucky 42303-1089
    United States

    Site Not Available

  • Clinical Trials Management, LLC - Covington /ID# 139651

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Clinical Trials Management,LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Ochsner Baptist Medical Center /ID# 139740

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Omni Fertility and Laser Insti /ID# 139836

    Shreveport, Louisiana 71118
    United States

    Site Not Available

  • Mercy Medical Center /ID# 152035

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • Capital Women's Care /ID# 144109

    Frederick, Maryland 21708
    United States

    Site Not Available

  • Genesis Clinical Research - Fall River /ID# 148449

    Fall River, Massachusetts 02723
    United States

    Site Not Available

  • Great Lakes Research Group,Inc /ID# 139659

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Grand Rapids Womens Health /ID# 139705

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Wayne State University Physician Group - Southfield /ID# 139802

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Saint Louis University /ID# 145936

    St.Louis, Missouri 63117
    United States

    Site Not Available

  • Mabey, Las Vegas, NV /ID# 148138

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Office of Edmond E. Pack, MD /ID# 139792

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Lawrence OB/GYN /ID# 143567

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Bosque Women's Care /ID# 145934

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Manhattan Medical Research /ID# 144471

    New York, New York 10016-6023
    United States

    Site Not Available

  • Cwrwc /Id# 139664

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Unified Women's Clinical Research-Greensboro /ID# 139829

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Unified Women's Clinical Resea /ID# 139774

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • PMG Research of Wilmington LLC /ID# 152563

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Unified Women's Clinical Resea /ID# 144721

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • University of Cincinnati /ID# 139820

    Cincinnati, Ohio 45267-0585
    United States

    Site Not Available

  • Univ Hosp Cleveland /ID# 139741

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Complete Healthcare for Women /ID# 139673

    Columbus, Ohio 43231
    United States

    Site Not Available

  • Miami Valley Hospital /ID# 144430

    Dayton, Ohio 45409
    United States

    Site Not Available

  • University of Toledo /ID# 139787

    Toledo, Ohio 43614
    United States

    Site Not Available

  • OU Physicians Urology /ID# 148690

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Legacy Medical Group-Portland /ID# 148807

    Portland, Oregon 97210
    United States

    Site Not Available

  • Main Line Fertility Center /ID# 150295

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Penn State University and Milton S. Hershey Medical Center /ID# 139733

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Temple University Hospital /ID# 151429

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Thomas Jefferson University /ID# 139812

    Philadelphia, Pennsylvania 19107-4414
    United States

    Site Not Available

  • Clinical Trials Research Svcs /ID# 139707

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 148754

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vista Clinical Research /ID# 139797

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • WR-ClinSearch /ID# 143538

    Chattanooga, Tennessee 37421-1605
    United States

    Site Not Available

  • Chattanooga GYN Oncology LLC /ID# 143538

    Hixon, Tennessee 37343
    United States

    Site Not Available

  • The Jackson Clinic, PA /ID# 151188

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Research Memphis Associates, LLC /ID# 139674

    Memphis, Tennessee 38119-3895
    United States

    Site Not Available

  • Access Clinical Trials, Inc. /ID# 139730

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tekton Research, Inc. /ID# 143984

    Austin, Texas 78739
    United States

    Site Not Available

  • UT Southwestern Medical Center /ID# 143537

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Advances in Health, Inc. /ID# 139672

    Houston, Texas 77030
    United States

    Site Not Available

  • Discovery Clinical Trials-San Antonio /ID# 139776

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Victorium Clinical Research /ID# 149630

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Houston Ctr for Clin Research /ID# 149149

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Houston Center for Clinical Research /ID# 149149

    Sugarland, Texas 77479
    United States

    Site Not Available

  • Baylor Scott & White Health /ID# 143982

    Temple, Texas 76508
    United States

    Site Not Available

  • Center of Reproductive Medicin /ID# 139813

    Webster, Texas 77598
    United States

    Site Not Available

  • Eastern Virginia Med School /ID# 139647

    Norfolk, Virginia 23507-1627
    United States

    Site Not Available

  • Clinical Research Partners, LL /ID# 143999

    North Chesterfield, Virginia 23235-4722
    United States

    Site Not Available

  • Clinical Trials Virginia, Inc. /ID# 139801

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Emerson Clinical Research /ID# 147373

    Vienna, Virginia 22182
    United States

    Site Not Available

  • Zain Research /ID# 139744

    Richland, Washington 99352
    United States

    Site Not Available

  • Seattle Women's Health, Research, Gynecology /ID# 139768

    Seattle, Washington 98105
    United States

    Site Not Available

  • Premier Clinical Research /ID# 148145

    Spokane, Washington 99202
    United States

    Site Not Available

  • Froedtert and Medical College /ID# 143566

    Milwaukee, Wisconsin 53226-3522
    United States

    Site Not Available

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