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)

Last updated: July 9, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Uterine Fibroids

Heavy Bleeding / Heavy Periods

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02691494
M12-817
  • 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: 378
Study Start date:
February 03, 2016
Estimated Completion Date:
January 23, 2019

Connect with a study center

  • Medicor Research Inc. /ID# 153406

    Sudbury, Ontario P3A 1W8
    Canada

    Site Not Available

  • Victory Reproductive Care /ID# 150247

    Windsor, Ontario N8W 5R7
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 153406

    Sudbury, Ontario, P3E 1B8
    Canada

    Site Not Available

  • Alabama Clinical Therapeutics, LLC /ID# 152258

    Birmingham, Alabama 35235-3430
    United States

    Site Not Available

  • Choice Research, LLC /ID# 150988

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Brown, Pearson, Guepet Gynecology /ID# 151020

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Mobile, Ob-Gyn, P.C. /ID# 144294

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Mesa Obstetricians and Gynecol /ID# 149139

    Mesa, Arizona 85209
    United States

    Site Not Available

  • Visions Clinical Research-Tucs /ID# 151017

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Core Healthcare Group /ID# 151016

    Cerritos, California 90703
    United States

    Site Not Available

  • Diagnamics Inc. /ID# 152469

    Encinitas, California 92024
    United States

    Site Not Available

  • HCP Clinical Research LLC /ID# 154434

    Huntington Beach, California 92646
    United States

    Site Not Available

  • Alliance Research Centers /ID# 149752

    Laguna Hills, California 92653-3621
    United States

    Site Not Available

  • University of California, Los Angeles /ID# 149760

    Los Angeles, California 90095
    United States

    Site Not Available

  • Futura Research, Inc. /ID# 149759

    Norwalk, California 90650
    United States

    Site Not Available

  • Healthcare Partners Med Group /ID# 154434

    Redondo Beach, California 90277-3416
    United States

    Site Not Available

  • Farid Yasharpour MD Medical Co /ID# 149770

    San Fernando, California 91340
    United States

    Site Not Available

  • Quest Clinical Research /ID# 149755

    San Francisco, California 94115
    United States

    Site Not Available

  • University of California, Los Angeles /ID# 149760

    Santa Monica, California 90404
    United States

    Site Not Available

  • Healthcare Partners Med Group

    Torrance, California 90503
    United States

    Site Not Available

  • Clinical Trial Investigators /ID# 152470

    Tustin, California 92780
    United States

    Site Not Available

  • Bayview Research Group LLC /ID# 153799

    Valley Village, California 91607
    United States

    Site Not Available

  • Emerson Clinical Research Inst /ID# 152348

    Washington, District of Columbia 20011
    United States

    Site Not Available

  • Emerson Clinical Research Institute /ID# 152348

    Washington, D.C., District of Columbia 20011
    United States

    Site Not Available

  • Ideal Clinical Research Inc. /ID# 149757

    Aventura, Florida 33180
    United States

    Site Not Available

  • Seffner Premier Health Care, P /ID# 167480

    Brandon, Florida 33510
    United States

    Site Not Available

  • Olympian Clinical Research /ID# 149756

    Clearwater, Florida 33756
    United States

    Site Not Available

  • KO Clinical Research, LLC /ID# 144299

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • University of Florida /ID# 149751

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Solutions Through Adv Rch /ID# 151021

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Meridien Research /ID# 167100

    Kenneth City, Florida 33709-3113
    United States

    Site Not Available

  • Axcess Medical Research /ID# 149769

    Loxahatchee, Florida 33470
    United States

    Site Not Available

  • Axcess Medical Research /ID# 149769

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Invictus Clinical Research Group,LLC /ID# 141859

    Miami, Florida 33144
    United States

    Site Not Available

  • Precision Research Org, LLC /ID# 144335

    Miami Lakes, Florida 33016-1501
    United States

    Site Not Available

  • Suncoast Clinical Research /ID# 149765

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Ideal Clinical Research Inc. /ID# 149757

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Alliance Womens Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • All Wmns HC of West Broward /ID# 144298

    Plantation, Florida 33324
    United States

    Site Not Available

  • Martin Health System Center for Clinical Research /ID# 152263

    Port Saint Lucie, Florida 34987
    United States

    Site Not Available

  • Martin Health System Center for Clinical Research /ID# 152263

    Port St. Lucie, Florida 34987
    United States

    Site Not Available

  • Oncova Clinical Research, Inc. /ID# 149764

    Saint Cloud, Florida 34769
    United States

    Site Not Available

  • Meridien Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Physician Care Clin. Res., LLC /ID# 149766

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Qps-Mra, Llc /Id# 144325

    South Miami, Florida 33143
    United States

    Site Not Available

  • Martin Health System Center /ID# 152263

    Stuart, Florida 34994
    United States

    Site Not Available

  • University of South Florida /ID# 149754

    Tampa, Florida 33612
    United States

    Site Not Available

  • Axcess Medical Research /ID# 149769

    Wellington, Florida 33414
    United States

    Site Not Available

  • Virtus Research Consultant,LLC /ID# 144296

    Wellington, Florida 33414
    United States

    Site Not Available

  • Paramount Research Solutions /ID# 149291

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Agile Clinical Research Trials /ID# 167074

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Atlanta Women's Research Inst /ID# 144303

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Mount Vernon Clinical Res, LLC /ID# 144297

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Georgia Regents University /ID# 144295

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Masters of Clinical Research, Inc. /ID# 167400

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Mount Vernon Clinical Research, LLC /ID# 144297

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Meridian Clinical Research, LLC /ID# 149144

    Savannah, Georgia 31406-2675
    United States

    Site Not Available

  • Gyn-Care, Inc. /ID# 149341

    Smyrna, Georgia 30080
    United States

    Site Not Available

  • Atlanta Gynecology Research Institute /ID# 151014

    Suwanee, Georgia 30024-7159
    United States

    Site Not Available

  • Womens Healthcare Assoc, DBA /ID# 149762

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Advanced Clinical Research /ID# 149767

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Women's Health Practice

    Champaign, Illinois 61820
    United States

    Site Not Available

  • University of Chicago /ID# 152257

    Chicago, Illinois 60637-1443
    United States

    Site Not Available

  • Affinity Clinical Research /ID# 167119

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Center for Women's Research, Inc /ID# 144300

    Palos Heights, Illinois 60463-1440
    United States

    Site Not Available

  • Women's Health Advantage /ID# 144301

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • Lafayette Clinical Research Group /ID# 144313

    Lafayette, Indiana 47905
    United States

    Site Not Available

  • The Iowa Clinic /ID# 150105

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • PRN Professional Research Network of Kansas, LLC /ID# 152265

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Bluegrass Clinical Research /ID# 150103

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Clinical Trials Management, LLC - Covington /ID# 144314

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Clinical Trials Management, LLC /ID# 144314

    Mandeville, Louisiana 70471
    United States

    Site Not Available

  • Clinical Trials Management,LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Women Under Study, LLC /ID# 144312

    New Orleans, Louisiana 70125-1923
    United States

    Site Not Available

  • Baltimore Suburban Health /ID# 154638

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Womens Health Center /ID# 154209

    Glen Burnie, Maryland 21063
    United States

    Site Not Available

  • Maryland Ctr for Sexual Health /ID# 149778

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Baltimore Suburban Health /ID# 154638

    Pikesville, Maryland 21208
    United States

    Site Not Available

  • NECCR of Fall River, LLC /ID# 149584

    Fall Revier, Massachusetts 02720
    United States

    Site Not Available

  • NECCR Fall River LLC /ID# 149584

    Fall River, Massachusetts 02720-2972
    United States

    Site Not Available

  • Saginaw Valley Med Res Group /ID# 149768

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Accent Clinical Trials /ID# 149753

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Accent Clinical Trials /ID# 149753

    Las Vegas, Nevada 89106-4017
    United States

    Site Not Available

  • Jersey Shore University Medical Center /ID# 149779

    Neptune, New Jersey 07753-4859
    United States

    Site Not Available

  • Jersey Shore University Medical Center /ID# 149779

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Rowan University SOM /ID# 152697

    Stratford, New Jersey 08084
    United States

    Site Not Available

  • Montefiore Medical Center /ID# 149582

    Bronx, New York 10461
    United States

    Site Not Available

  • SUNY Downstate Medical Center /ID# 144311

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Manhattan Medical Research /ID# 167077

    New York, New York 10016-6023
    United States

    Site Not Available

  • Weill Cornell Medicine /ID# 149585

    New York, New York 10032-3725
    United States

    Site Not Available

  • Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Unified Women's Clinical Research-Greensboro /ID# 149588

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Pinewest Ob-Gyn, Inc. /ID# 145671

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Eastern Carolina Women's Centr /ID# 144309

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Wake Research Associates, LLC /ID# 144307

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Wilmingtnon Health, PLLC /ID# 167335

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Clinical Inquest Center Ltd /ID# 148728

    Beavercreek, Ohio 45432
    United States

    Site Not Available

  • CTI Clinical Research Center /ID# 149761

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • The Christ Hospital /ID# 150104

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Alpha Research Associates LLC /ID# 152471

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Comprehensive Womens Care /ID# 144306

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Oregon Health & Science University (OHSU) /ID# 144308

    Portland, Oregon 97239
    United States

    Site Not Available

  • Family Medical Associates /ID# 145668

    Levittown, Pennsylvania 19056
    United States

    Site Not Available

  • Clinical Research of Philadelphia, LLC /ID# 151015

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • University of Pennsylvania /ID# 149586

    Philadelphia, Pennsylvania 19104-5502
    United States

    Site Not Available

  • Reading Hosp Clncl Trials Ofc /ID# 149583

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Holston Medical Group /ID# 149763

    Bristol, Tennessee 37620-7346
    United States

    Site Not Available

  • Chattanooga Medical Research /ID# 145667

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Chattanooga Women for Women

    Hixon, Tennessee 37343
    United States

    Site Not Available

  • Chattanooga Women for Women /ID# 167051

    Hixson, Tennessee 37343-3992
    United States

    Site Not Available

  • The Jackson Clinic, PA /ID# 145670

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • The Womens Physician Group /ID# 144317

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Access Clinical Trials, Inc. /ID# 167333

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Lotus Gynecology /ID# 149140

    Austin, Texas 78703-1448
    United States

    Site Not Available

  • Inquest Clinical Research /ID# 149755

    Baytown, Texas 77521-2415
    United States

    Site Not Available

  • Texas Health Presbyterian Hosp /ID# 149142

    Dallas, Texas 75231
    United States

    Site Not Available

  • Baylor Research Institute /ID# 149141

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Willowbend Health and Wellness Associates /ID# 144318

    Frisco, Texas 75035
    United States

    Site Not Available

  • BI Research Center /ID# 149143

    Houston, Texas 77084
    United States

    Site Not Available

  • Baylor College of Medicine /ID# 149141

    Houston, Texas 77030-3411
    United States

    Site Not Available

  • Centex Studies, Inc. - Houston /ID# 150106

    Houston, Texas 77058
    United States

    Site Not Available

  • The Woman's Hospital of Texas /ID# 144319

    Houston, Texas 77054
    United States

    Site Not Available

  • FMC Science /ID# 151802

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Willowbend Health and Wellness /ID# 144318

    Plano, Texas 75035
    United States

    Site Not Available

  • Clinical Trials of Texas,Inc. /ID# 144322

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Houston Ctr for Clin Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Center of Reproductive Medicin /ID# 167235

    Webster, Texas 77598
    United States

    Site Not Available

  • Southampton Women's Health /ID# 152325

    Franklin, Virginia 23851
    United States

    Site Not Available

  • Clinical Research Partners, LL

    Henrico, Virginia 23233
    United States

    Site Not Available

  • Tidewater Physicians for Women /ID# 144321

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Clinical Research Partners, LL /ID# 167064

    North Chesterfield, Virginia 23235-4722
    United States

    Site Not Available

  • Alliance Womens Health /ID# 152468

    Richmond, Virginia 23226-1930
    United States

    Site Not Available

  • Clinical Research Partners, LLC /ID# 144310

    Richmond, Virginia 23220-4459
    United States

    Site Not Available

  • Zain Research /ID# 151018

    Richland, Washington 99352
    United States

    Site Not Available

  • Virginia Mason Medical Center /ID# 149758

    Seattle, Washington 98101
    United States

    Site Not Available

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