An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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

Phase

3

Condition

Dysfunctional Uterine Bleeding

Heavy Bleeding / Heavy Periods

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02925494
M12-816
  • Ages 18-51
  • Female

Study Summary

This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has completed the 6-Month Treatment Period of their respective PivotalStudy (either Study M12-815 or Study M12-817).
  • Participant did not meet removal criteria in bone mineral density (BMD) decrease inthe spine, total hip and femoral neck at Month 6 of the Treatment Period of theirrespective Pivotal Study
  • Participant has negative urine and/or serum pregnancy test(s) results wereconsistently negative during the Treatment Period of their respective Pivotal Studyand prior to first dose in this study.
  • Participant's endometrial biopsy from the Month 6 Visit of their respective PivotalStudy shows no clinically significant endometrial pathology.

Exclusion

Exclusion Criteria:

  • Participant met criteria for removal from therapy in her respective Pivotal Study.
  • Participant is planning a pregnancy within the next 18 months.
  • Participant has current suicidal markers as noted at the Month 6 visit of herrespective 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 torequire treatment with systemic corticosteroids during the course of the study.Over-the-counter and prescription topical, inhaled, intranasal or injectable (foroccasional use) corticosteroids are allowed.

Study Design

Total Participants: 433
Study Start date:
September 14, 2016
Estimated Completion Date:
March 22, 2019

Connect with a study center

  • Victory Reproductive Care /ID# 153299

    Windsor, Ontario N8W 5R7
    Canada

    Site Not Available

  • University of Puerto Rico, School of Medicine /ID# 153329

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Rodriguez-Ginorio, San Juan /ID# 153328

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Alabama Clinical Therapeutics, LLC /ID# 153217

    Birmingham, Alabama 35235-3430
    United States

    Site Not Available

  • Alabama Clinical Therapeutics, LLC /ID# 153336

    Birmingham, Alabama 35235-3430
    United States

    Site Not Available

  • Choice Research, LLC /ID# 153492

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Brown, Pearson, Guepet Gynecology /ID# 153278

    Fairhope, Alabama 36532
    United States

    Site Not Available

  • Mobile, Ob-Gyn, P.C. /ID# 153442

    Mobile, Alabama 36608
    United States

    Site Not Available

  • University of South Alabama /ID# 153415

    Mobile, Alabama 36604-3302
    United States

    Site Not Available

  • Mesa Obstetricians and Gynecol /ID# 153269

    Mesa, Arizona 85209
    United States

    Site Not Available

  • Visions Clinical Research-Tucson /ID# 153286

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Core Healthcare Group /ID# 153282

    Cerritos, California 90703
    United States

    Site Not Available

  • Diagnamics Inc. /ID# 153347

    Encinitas, California 92024
    United States

    Site Not Available

  • Grossmont Ctr Clin Research /ID# 153324

    La Mesa, California 91942
    United States

    Site Not Available

  • Futura Research, Inc. /ID# 153345

    Norwalk, California 90650
    United States

    Site Not Available

  • Farid Yasharpour MD Medical Co /ID# 153482

    San Fernando, California 91340
    United States

    Site Not Available

  • Bayview Research Group /ID# 169593

    Valley Village, California 91607
    United States

    Site Not Available

  • Advanced Women's Health Instit

    Denver, Colorado 80246
    United States

    Site Not Available

  • Advanced Women's Health Institution /ID# 153401

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Emerson Clinical Research Inst /ID# 162755

    Washington, District of Columbia 20011
    United States

    Site Not Available

  • James A. Simon, MD, PC /ID# 153323

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Medstar Health Research Institute /ID# 153321

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center /ID# 153321

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

    Site Not Available

  • Helix Biomedics, LLC /ID# 153440

    Boynton Beach, Florida 33436-6634
    United States

    Site Not Available

  • Brandon Premier Health Care, PA /ID# 165791

    Brandon, Florida 33510-3107
    United States

    Site Not Available

  • Florida Fertility Institute /ID# 153308

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Omega Research Consultants, LLC /ID# 153381

    DeBary, Florida 32713-2260
    United States

    Site Not Available

  • KO Clinical Research, LLC /ID# 153198

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Clinical Physiology Assoc. /ID# 153444

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Solutions Through Adv Rch /ID# 153283

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Meridien Research /ID# 153310

    Kenneth City, Florida 33709-3113
    United States

    Site Not Available

  • Altus Research, Inc /ID# 153307

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Axcess Medical Research /ID# 153500

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • South Florida Wellness & Clinic /ID# 153420

    Margate, Florida 33063
    United States

    Site Not Available

  • Healthcare Clinical Data, Inc /ID# 153425

    Miami, Florida 33161
    United States

    Site Not Available

  • Invictus Clinical Research Group,LLC /ID# 153196

    Miami, Florida 33144
    United States

    Site Not Available

  • LCC Medical Research Institute /ID# 153296

    Miami, Florida 33126
    United States

    Site Not Available

  • Ocean Blue Med Research Ctr /ID# 153225

    Miami, Florida 33166
    United States

    Site Not Available

  • Precision Research Org, LLC /ID# 153276

    Miami Lakes, Florida 33016-1501
    United States

    Site Not Available

  • Ocean Blue Medical Research Center, Inc. /ID# 153225

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Advanced Research Institute /ID# 153413

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Suncoast Clinical Research /ID# 153206

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Healthcare Clinical Data, Inc. /ID# 153425

    North Miami, Florida 33161
    United States

    Site Not Available

  • Clinical Associates of Orlando /ID# 153427

    Orlando, Florida 32806
    United States

    Site Not Available

  • Unified Womens Clin Research /ID# 153229

    Panama City, Florida 32045
    United States

    Site Not Available

  • All Wmns HC of West Broward /ID# 153434

    Plantation, Florida 33324
    United States

    Site Not Available

  • Oncova Clinical Research, Inc. /ID# 153497

    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# 153210

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Qps-Mra, Llc /Id# 153456

    South Miami, Florida 33143
    United States

    Site Not Available

  • Meridien Research /ID# 153310

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • University of South Florida /ID# 153271

    Tampa, Florida 33612
    United States

    Site Not Available

  • Axcess Medical Research /ID# 153500

    Wellington, Florida 33414
    United States

    Site Not Available

  • Virtus Research Consultant,LLC /ID# 153398

    Wellington, Florida 33414
    United States

    Site Not Available

  • Comprehensive Clinical Trials /ID# 153350

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Atlanta Medical Research Insti /ID# 153298

    Alpharetta, Georgia 30005-4419
    United States

    Site Not Available

  • Paramount Research Solutions /ID# 153424

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Paramount Research Solutions /ID# 160974

    Alpharetta, Georgia 30005
    United States

    Site Not Available

  • Atlanta Women's Research Inst /ID# 153212

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Mount Vernon Clinical Res, LLC /ID# 153403

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Masters of Clinical Research, Inc. /ID# 153295

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Paramount Research Solutions /ID# 153351

    College Park, Georgia 30349
    United States

    Site Not Available

  • Mount Vernon Clinical Research, LLC /ID# 153403

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Fellows Research Alliance, Inc /ID# 153227

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Atlanta Gynecology Research Institute /ID# 200074

    Suwanee, Georgia 30024-7159
    United States

    Site Not Available

  • Clinical Research Consultants of Atlanta /ID# 153285

    Suwanee, Georgia 30024-6988
    United States

    Site Not Available

  • Boise Family Medicine Center

    Boise, Idaho 83709
    United States

    Site Not Available

  • Sonora Clinical Research /ID# 153231

    Meridian, Idaho 83646-1144
    United States

    Site Not Available

  • The University of Chicago /ID# 153334

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Affinity Clinical Research /ID# 153417

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Women's Health Advantage /ID# 153208

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • Bluegrass Clinical Research /ID# 153280

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Clinical Trials Management, LLC - Covington /ID# 153211

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Clinical Trials Management, LLC - Covington /ID# 153439

    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# 153459

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Omni Fertility and Laser Insti /ID# 153228

    Shreveport, Louisiana 71118
    United States

    Site Not Available

  • Baltimore Suburban Health /ID# 168386

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Genesis Clinical Research /ID# 153379

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • NECCR Fall River LLC /ID# 153274

    Fall River, Massachusetts 02720-2972
    United States

    Site Not Available

  • Great Lakes Research Group,Inc /ID# 153302

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Saginaw Valley Med Res Group /ID# 153498

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Wayne State University Physician Group - Southfield /ID# 153418

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Accent Clinical Trials /ID# 153474

    Las Vegas, Nevada 89106-4017
    United States

    Site Not Available

  • Mabey, Las Vegas, NV /ID# 153314

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Office of Edmond E. Pack, MD /ID# 153411

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Lawrence OB/GYN /ID# 153218

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Jersey Shore University Medical Center /ID# 153495

    Neptune, New Jersey 07753-4859
    United States

    Site Not Available

  • Jersey Shore University Medical Center /ID# 153495

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Bosque Women's Care /ID# 153223

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • SUNY Downstate Medical Center /ID# 153344

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Manhattan Medical Research /ID# 153386

    New York, New York 10016-6023
    United States

    Site Not Available

  • Weill Cornell Medicine /ID# 153275

    New York, New York 10032-3725
    United States

    Site Not Available

  • Cwrwc /Id# 153313

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Unified Women's Clinical Resea /ID# 153479

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Unified Women's Clinical Research-Greensboro /ID# 153499

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Pinewest Ob-Gyn, Inc. /ID# 153197

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Eastern Carolina Women's Centr /ID# 153341

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Unified Women's Clinical Resea /ID# 153312

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Wake Research Associates, LLC /ID# 153402

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Unified Women's Clinical Resea /ID# 153297

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Clinical Inquest Center Ltd /ID# 153436

    Beavercreek, Ohio 45432
    United States

    Site Not Available

  • CTI Clinical Research Center /ID# 153201

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • University Hospitals Cleveland /ID# 153450

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Wright State University & Premier Health CTRA /ID# 153222

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • University of Toledo /ID# 153409

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Comprehensive Womens Care /ID# 153396

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Legacy Medical Group-Portland /ID# 168286

    Portland, Oregon 97210
    United States

    Site Not Available

  • Main Line Fertility Center /ID# 153410

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Penn State University and Milton S. Hershey Medical Center /ID# 153443

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Family Medical Associates /ID# 153457

    Levittown, Pennsylvania 19056
    United States

    Site Not Available

  • Clinical Research of Philadelphia, LLC /ID# 153279

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Thomas Jefferson University /ID# 153319

    Philadelphia, Pennsylvania 19107-4414
    United States

    Site Not Available

  • University of Pennsylvania /ID# 153203

    Philadelphia, Pennsylvania 19104-5502
    United States

    Site Not Available

  • Reading Hosp Clncl Trials Ofc /ID# 153475

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Medical University of South Carolina /ID# 153325

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vista Clinical Research /ID# 153399

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Chattanooga Medical Research /ID# 153405

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • WR-ClinSearch /ID# 153404

    Chattanooga, Tennessee 37421-1605
    United States

    Site Not Available

  • Chattanooga Women for Women

    Hixon, Tennessee 37343
    United States

    Site Not Available

  • Chattanooga Women for Women /ID# 153404

    Hixson, Tennessee 37343-3992
    United States

    Site Not Available

  • Research Memphis Associates, LLC /ID# 153322

    Memphis, Tennessee 38119-3895
    United States

    Site Not Available

  • Women's Health Trials /ID# 153426

    Menphis, Tennessee 38104
    United States

    Site Not Available

  • Access Clinical Trials, Inc. /ID# 153441

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Lotus Gynecology /ID# 153476

    Austin, Texas 78703-1448
    United States

    Site Not Available

  • Texas Health Presbyterian Hosp /ID# 153339

    Dallas, Texas 75231
    United States

    Site Not Available

  • UT Southwestern Medical Center /ID# 153400

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Baylor Scott & White /ID# 153273

    Fort Worth, Texas 76104-4110
    United States

    Site Not Available

  • Willowbend Health and Wellness /ID# 153458

    Frisco, Texas 75035
    United States

    Site Not Available

  • Advances in Health, Inc. /ID# 153414

    Houston, Texas 77030
    United States

    Site Not Available

  • The Woman's Hospital of Texas /ID# 153270

    Houston, Texas 77054
    United States

    Site Not Available

  • FMC Science /ID# 153289

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Clinical Trials of Texas,Inc. /ID# 153209

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Discovery Clinical Trials-San Antonio /ID# 153315

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Houston Ctr for Clin Research /ID# 153221

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Center of Reproductive Medicin /ID# 153320

    Webster, Texas 77598
    United States

    Site Not Available

  • Clinical Research Partners, LL

    Henrico, Virginia 23233
    United States

    Site Not Available

  • Eastern Virginia Med School /ID# 153380

    Norfolk, Virginia 23507-1627
    United States

    Site Not Available

  • Tidewater Physicians for Women /ID# 153432

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Clinical Research Partners, LL /ID# 153412

    North Chesterfield, Virginia 23235-4722
    United States

    Site Not Available

  • Clinical Research Partners, LLC /ID# 153343

    Richmond, Virginia 23220-4459
    United States

    Site Not Available

  • Clinical Trials Virginia, Inc. /ID# 153419

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Emerson Clinical Research Inst /ID# 153416

    Vienna, Virginia 22182
    United States

    Site Not Available

  • Seattle Women's Health, Research, Gynecology /ID# 153306

    Seattle, Washington 98105
    United States

    Site Not Available

  • Virginia Mason Medical Center /ID# 153342

    Seattle, Washington 98101
    United States

    Site Not Available

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