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AzTrials

Uterine FibroidsPhase 3NCT02925494

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

A Phase 3 study testing Estradiol/Norethindrone Acetate and Elagolix in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by AbbVie at 124 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 51 years, women only
Conditions the study is for
Uterine Fibroids, Heavy Menstrual Bleeding
What is being tested?
Estradiol/Norethindrone Acetate and Elagolix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
433 participants
Where
124 sitesin 3 countries
Study dates
14 Sep 2016to 22 Mar 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 51 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
  • 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.

Who cannot join

  • 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 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.

Trial locations and contacts

124 sites in 3 countries.

124 sites in 3 countries

United States121 sites

  • Bosque Women's Care /ID# 153223

    Albuquerque, New Mexico, 87109

  • Atlanta Medical Research Insti /ID# 153298

    Alpharetta, Georgia, 30005-4419

  • Paramount Research Solutions /ID# 153424

    Alpharetta, Georgia, 30005

  • Paramount Research Solutions /ID# 160974

    Alpharetta, Georgia, 30005

  • Mount Vernon Clinical Res, LLC /ID# 153403

    Atlanta, Georgia, 30328

  • Atlanta Women's Research Inst /ID# 153212

    Atlanta, Georgia, 30342

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

    Augusta, Georgia, 30909

  • Lotus Gynecology /ID# 153476

    Austin, Texas, 78703-1448

  • Baltimore Suburban Health /ID# 168386

    Baltimore, Maryland, 21208

  • Great Lakes Research Group,Inc /ID# 153302

    Bay City, Michigan, 48706

  • Clinical Inquest Center Ltd /ID# 153436

    Beavercreek, Ohio, 45432

  • Alabama Clinical Therapeutics, LLC /ID# 153217

    Birmingham, Alabama, 35235-3430

  • Alabama Clinical Therapeutics, LLC /ID# 153336

    Birmingham, Alabama, 35235-3430

  • Helix Biomedics, LLC /ID# 153440

    Boynton Beach, Florida, 33436-6634

  • Brandon Premier Health Care, PA /ID# 165791

    Brandon, Florida, 33510-3107

  • SUNY Downstate Medical Center /ID# 153344

    Brooklyn, New York, 11203

  • Main Line Fertility Center /ID# 153410

    Bryn Mawr, Pennsylvania, 19010

  • Core Healthcare Group /ID# 153282

    Cerritos, California, 90703

  • Medical University of South Carolina /ID# 153325

    Charleston, South Carolina, 29425

  • Chattanooga Medical Research /ID# 153405

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch /ID# 153404

    Chattanooga, Tennessee, 37421-1605

  • CTI Clinical Research Center /ID# 153201

    Cincinnati, Ohio, 45212

  • Florida Fertility Institute /ID# 153308

    Clearwater, Florida, 33759

  • University Hospitals Cleveland /ID# 153450

    Cleveland, Ohio, 44106

  • Paramount Research Solutions /ID# 153351

    College Park, Georgia, 30349

  • Vista Clinical Research /ID# 153399

    Columbia, South Carolina, 29201

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

    Covington, Louisiana, 70433

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

    Covington, Louisiana, 70433

  • Texas Health Presbyterian Hosp /ID# 153339

    Dallas, Texas, 75231

  • UT Southwestern Medical Center /ID# 153400

    Dallas, Texas, 75390-7208

  • Omega Research Consultants, LLC /ID# 153381

    DeBary, Florida, 32713-2260

  • Choice Research, LLC /ID# 153492

    Dothan, Alabama, 36303

  • Cwrwc /Id# 153313

    Durham, North Carolina, 27713

  • Diagnamics Inc. /ID# 153347

    Encinitas, California, 92024

  • Brown, Pearson, Guepet Gynecology /ID# 153278

    Fairhope, Alabama, 36532

  • NECCR Fall River LLC /ID# 153274

    Fall River, Massachusetts, 02720-2972

  • Genesis Clinical Research /ID# 153379

    Fall River, Massachusetts, 02720

  • KO Clinical Research, LLC /ID# 153198

    Fort Lauderdale, Florida, 33316

  • Clinical Physiology Assoc. /ID# 153444

    Fort Myers, Florida, 33916

  • Baylor Scott & White /ID# 153273

    Fort Worth, Texas, 76104-4110

  • Willowbend Health and Wellness /ID# 153458

    Frisco, Texas, 75035

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

    Greensboro, North Carolina, 27408

  • Advanced Women's Health Institution /ID# 153401

    Greenwood Village, Colorado, 80111

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

    Hershey, Pennsylvania, 17033

  • Pinewest Ob-Gyn, Inc. /ID# 153197

    High Point, North Carolina, 27262

  • Advances in Health, Inc. /ID# 153414

    Houston, Texas, 77030

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

    Houston, Texas, 77054

  • Solutions Through Adv Rch /ID# 153283

    Jacksonville, Florida, 32256

  • Meridien Research /ID# 153310

    Kenneth City, Florida, 33709-3113

  • Grossmont Ctr Clin Research /ID# 153324

    La Mesa, California, 91942

  • Altus Research, Inc /ID# 153307

    Lake Worth, Florida, 33461

  • FMC Science /ID# 153289

    Lampasas, Texas, 76550

  • Accent Clinical Trials /ID# 153474

    Las Vegas, Nevada, 89106-4017

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

    Las Vegas, Nevada, 89113

  • Mabey, Las Vegas, NV /ID# 153314

    Las Vegas, Nevada, 89128

  • Lawrence OB/GYN /ID# 153218

    Lawrenceville, New Jersey, 08648

  • Bluegrass Clinical Research /ID# 153280

    Louisville, Kentucky, 40291

  • South Florida Wellness & Clinic /ID# 153420

    Margate, Florida, 33063

  • Research Memphis Associates, LLC /ID# 153322

    Memphis, Tennessee, 38119-3895

  • Women's Health Trials /ID# 153426

    Menphis, Tennessee, 38104

  • Sonora Clinical Research /ID# 153231

    Meridian, Idaho, 83646-1144

  • Mesa Obstetricians and Gynecol /ID# 153269

    Mesa, Arizona, 85209

  • LCC Medical Research Institute /ID# 153296

    Miami, Florida, 33126

  • Invictus Clinical Research Group,LLC /ID# 153196

    Miami, Florida, 33144

  • Healthcare Clinical Data, Inc /ID# 153425

    Miami, Florida, 33161

  • Ocean Blue Med Research Ctr /ID# 153225

    Miami, Florida, 33166

  • Precision Research Org, LLC /ID# 153276

    Miami Lakes, Florida, 33016-1501

  • University of South Alabama /ID# 153415

    Mobile, Alabama, 36604-3302

  • Mobile, Ob-Gyn, P.C. /ID# 153442

    Mobile, Alabama, 36608

  • Access Clinical Trials, Inc. /ID# 153441

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center /ID# 153495

    Neptune City, New Jersey, 07753-4859

  • Eastern Carolina Women's Centr /ID# 153341

    New Bern, North Carolina, 28562

  • Ochsner Baptist Medical Center /ID# 153459

    New Orleans, Louisiana, 70115

  • Suncoast Clinical Research /ID# 153206

    New Port Richey, Florida, 34652

  • Advanced Research Institute /ID# 153413

    New Port Richey, Florida, 34653

  • Manhattan Medical Research /ID# 153386

    New York, New York, 10016-6023

  • Weill Cornell Medicine /ID# 153275

    New York, New York, 10032-3725

  • Tidewater Physicians for Women /ID# 153432

    Norfolk, Virginia, 23502

  • Eastern Virginia Med School /ID# 153380

    Norfolk, Virginia, 23507-1627

  • Clinical Research Partners, LL /ID# 153412

    North Chesterfield, Virginia, 23235-4722

  • Futura Research, Inc. /ID# 153345

    Norwalk, California, 90650

  • Affinity Clinical Research /ID# 153417

    Oak Brook, Illinois, 60523

  • Clinical Associates of Orlando /ID# 153427

    Orlando, Florida, 32806

  • Unified Womens Clin Research /ID# 153229

    Panama City, Florida, 32045

  • University of Pennsylvania /ID# 153203

    Philadelphia, Pennsylvania, 19104-5502

  • Thomas Jefferson University /ID# 153319

    Philadelphia, Pennsylvania, 19107-4414

  • Clinical Research of Philadelphia, LLC /ID# 153279

    Philadelphia, Pennsylvania, 19114

  • All Wmns HC of West Broward /ID# 153434

    Plantation, Florida, 33324

  • Legacy Medical Group-Portland /ID# 168286

    Portland, Oregon, 97210

  • Unified Women's Clinical Resea /ID# 153312

    Raleigh, North Carolina, 27607

  • Wake Research Associates, LLC /ID# 153402

    Raleigh, North Carolina, 27612

  • Clinical Research Partners, LLC /ID# 153343

    Richmond, Virginia, 23220-4459

  • Clinical Trials Virginia, Inc. /ID# 153419

    Richmond, Virginia, 23225

  • Saginaw Valley Med Res Group /ID# 153498

    Saginaw, Michigan, 48604

  • Oncova Clinical Research, Inc. /ID# 153497

    Saint Cloud, Florida, 34769

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

    San Antonio, Texas, 78229

  • Discovery Clinical Trials-San Antonio /ID# 153315

    San Antonio, Texas, 78258

  • Farid Yasharpour MD Medical Co /ID# 153482

    San Fernando, California, 91340

  • Physician Care Clin. Res., LLC /ID# 153210

    Sarasota, Florida, 34239

  • Fellows Research Alliance, Inc /ID# 153227

    Savannah, Georgia, 31406

  • Virginia Mason Medical Center /ID# 153342

    Seattle, Washington, 98101

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

    Seattle, Washington, 98105

  • Omni Fertility and Laser Insti /ID# 153228

    Shreveport, Louisiana, 71118

  • Qps-Mra, Llc /Id# 153456

    South Miami, Florida, 33143

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

    Southfield, Michigan, 48034

  • Houston Ctr for Clin Research /ID# 153221

    Sugar Land, Texas, 77479

  • Clinical Research Consultants of Atlanta /ID# 153285

    Suwanee, Georgia, 30024-6988

  • Atlanta Gynecology Research Institute /ID# 200074

    Suwanee, Georgia, 30024-7159

  • University of South Florida /ID# 153271

    Tampa, Florida, 33612

  • University of Toledo /ID# 153409

    Toledo, Ohio, 43614

  • Emerson Clinical Research Inst /ID# 153416

    Vienna, Virginia, 22182

  • Medstar Health Research Institute /ID# 153321

    Washington D.C., District of Columbia, 20010

  • Emerson Clinical Research Inst /ID# 162755

    Washington D.C., District of Columbia, 20011

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

    Washington D.C., District of Columbia, 20036

  • Center of Reproductive Medicin /ID# 153320

    Webster, Texas, 77598

  • Axcess Medical Research /ID# 153500

    Wellington, Florida, 33414

  • Virtus Research Consultant,LLC /ID# 153398

    Wellington, Florida, 33414

  • Comprehensive Clinical Trials /ID# 153350

    West Palm Beach, Florida, 33409

  • Reading Hosp Clncl Trials Ofc /ID# 153475

    West Reading, Pennsylvania, 19611

  • Comprehensive Womens Care /ID# 153396

    Westerville, Ohio, 43081

  • Unified Women's Clinical Resea /ID# 153297

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Rodriguez-Ginorio, San Juan /ID# 153328

    San Juan, 00917

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

    San Juan, 00935

Other trials in Puerto Rico

Canada1 site

  • Victory Reproductive Care /ID# 153299

    Windsor, Ontario, N8W 5R7

Other trials in Canada

About this study

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

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.

Being tested
Estradiol/Norethindrone Acetate, Elagolix
Keywords
Uterine Fibroids, Elagolix, Heavy Menstrual Bleeding, Elagolix Sodium, Elagolix plus Norethindrone Acetate
Medical subject headings
Leiomyoma, Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol/Norethindrone AcetateDrug

    capsules

  • ElagolixDrug

    Also called ABT-620, elagolix sodium

    film-coated tablets

Study groups in NCT02925494
Study groupRoleWhat they receive
Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)ExperimentalElagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
Receives: Drug: Estradiol/Norethindrone Acetate; Drug: Elagolix
ElagolixExperimentalElagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Receives: Drug: Elagolix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Meeting the Criteria for Responder

    Percentage of responders, defined as participants who met the following conditions:

    • Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and
    • ≥ 50% reduction in MBL volume from Baseline to the Final Month.

    Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.

    Measured: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)

Secondary outcomes (4)

  1. Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period

    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.

    Measured: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)

  2. Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period

    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.

    Measured: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)

  3. Percentage of Participants With Suppression of Bleeding at the Final Month

    Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.

    Measured: Final Month of Treatment Period (up through Month 6)

  4. Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start14 Sep 2016
  3. Primary completion7 May 2018
  4. Study completion22 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
433 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925494
Sponsor's protocol ID
M12-816
Status last verified
Jul 2021
First submitted
24 Sep 2016
Last updated
13 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • 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.

    PubMed 32459423

  • 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.

    PubMed 34878624

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estradiol/Norethindrone Acetate and Elagolix in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by AbbVie at 124 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Puerto Rico, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Meeting the Criteria for Responder (time frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02925494, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.

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