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Uterine FibroidsPhase 3NCT02654054

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

A Phase 3 study testing Elagolix and Estradiol/Norethindrone Acetate in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by AbbVie at 96 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial 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. 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?
Elagolix and Estradiol/Norethindrone Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
413 participants
Where
96 sitesin 3 countries
Study dates
22 Dec 2015to 12 Dec 2018
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

  • 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 by menstrual blood loss > 80 mL during each of two screening menses as measured by the alkaline hematin method.
  • Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
  • Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Who cannot join

  • Subject has screening pelvic ultrasound or saline infusion sonohysterography results that 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, or urinalysis.
  • 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 any time (e.g., schizophrenia, bipolar disorder).
  • Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening 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

96 sites in 3 countries.

96 sites in 3 countries

United States92 sites

  • Bosque Women's Care /ID# 145934

    Albuquerque, New Mexico, 87109

  • Atlanta Medical Research Insti /ID# 147117

    Alpharetta, Georgia, 30005-4419

  • Paramount Research Solutions /ID# 139645

    Alpharetta, Georgia, 30005

  • Agile Clinical Research Trials /ID# 143563

    Atlanta, Georgia, 30328

  • Perimeter Inst Clinical Resear /ID# 148298

    Atlanta, Georgia, 30338

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

    Augusta, Georgia, 30909

  • American Health Network of IN /ID# 139822

    Avon, Indiana, 46123

  • Great Lakes Research Group,Inc /ID# 139659

    Bay City, Michigan, 48706

  • Summers, Birmingham, AL /ID# 139684

    Birmingham, Alabama, 35235

  • Boise Family Medical Center /ID# 139844

    Boise, Idaho, 83709

  • Helix Biomedics, LLC /ID# 147114

    Boynton Beach, Florida, 33436-6634

  • Brandon Premier Health Care, PA /ID# 153130

    Brandon, Florida, 33510-3107

  • Main Line Fertility Center /ID# 150295

    Bryn Mawr, Pennsylvania, 19010

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

    Champaign, Illinois, 61820

  • Medical University of South Carolina /ID# 148754

    Charleston, South Carolina, 29425

  • WR-ClinSearch /ID# 143538

    Chattanooga, Tennessee, 37421-1605

  • Great Lakes Clinical Trials /ID# 148135

    Chicago, Illinois, 60640

  • University of Cincinnati /ID# 139820

    Cincinnati, Ohio, 45267-0585

  • Florida Clin Res Group /ID# 139811

    Ckearwater, Florida, 33759

  • Univ Hosp Cleveland /ID# 139741

    Cleveland, Ohio, 44106

  • Bluebird Clinical Trials, LLC /ID# 144843

    Colorado Springs, Colorado, 80923

  • Vista Clinical Research /ID# 139797

    Columbia, South Carolina, 29201

  • Complete Healthcare for Women /ID# 139673

    Columbus, Ohio, 43231

  • WCCT Global, LLC /ID# 145666

    Costa Mesa, California, 92626

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

    Covington, Louisiana, 70433

  • UT Southwestern Medical Center /ID# 143537

    Dallas, Texas, 75390-7208

  • Miami Valley Hospital /ID# 144430

    Dayton, Ohio, 45409

  • Universal Clinical Research A /ID# 139742

    Doral, Florida, 33166

  • Cwrwc /Id# 139664

    Durham, North Carolina, 27713

  • Genesis Clinical Research - Fall River /ID# 148449

    Fall River, Massachusetts, 02723

  • Clinical Physiology Associates /ID# 139736

    Fort Myers, Florida, 33912

  • Capital Women's Care /ID# 144109

    Frederick, Maryland, 21708

  • Grand Rapids Womens Health /ID# 139705

    Grand Rapids, Michigan, 49503

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

    Greensboro, North Carolina, 27408

  • Advanced Women's Health Institution /ID# 144108

    Greenwood Village, Colorado, 80111

  • American Clinical Trials /ID# 147374

    Hawaiian Gardens, California, 90716

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

    Hershey, Pennsylvania, 17033

  • Advances in Health, Inc. /ID# 139672

    Houston, Texas, 77030

  • GTC Research /ID# 141854

    Kansas City, Kansas, 66218

  • Meridien Research /ID# 139663

    Kenneth City, Florida, 33709-3113

  • Grossmont Ctr Clin Research /ID# 144011

    La Mesa, California, 91942

  • Altus Research, Inc /ID# 139662

    Lake Worth, Florida, 33461

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

    Las Vegas, Nevada, 89113

  • Mabey, Las Vegas, NV /ID# 148138

    Las Vegas, Nevada, 89128

  • Lawrence OB/GYN /ID# 143567

    Lawrenceville, New Jersey, 08648

  • Long Beach Clinical Trial Serv /ID# 152424

    Long Beach, California, 90806

  • National Research Institute /ID# 151629

    Los Angeles, California, 90057

  • University of California, Los Angeles /ID# 144107

    Los Angeles, California, 90095

  • South Florida Wellness & Clinic /ID# 143558

    Margate, Florida, 33063

  • Research Memphis Associates, LLC /ID# 139674

    Memphis, Tennessee, 38119-3895

  • LCC Medical Research Institute /ID# 143551

    Miami, Florida, 33126

  • Healthcare Clinical Data, Inc /ID# 139650

    Miami, Florida, 33161

  • Ocean Blue Med Research Ctr /ID# 139826

    Miami, Florida, 33166

  • Froedtert and Medical College /ID# 143566

    Milwaukee, Wisconsin, 53226-3522

  • Salom Tangir, LLC /ID# 151732

    Miramar, Florida, 33027

  • University of South Alabama /ID# 148763

    Mobile, Alabama, 36604-3302

  • Access Clinical Trials, Inc. /ID# 139730

    Nashville, Tennessee, 37203

  • Ochsner Baptist Medical Center /ID# 139740

    New Orleans, Louisiana, 70115

  • Advanced Research Institute /ID# 143554

    New Port Richey, Florida, 34653

  • Manhattan Medical Research /ID# 144471

    New York, New York, 10016-6023

  • Beach OBGYN Medical Group /ID# 151414

    Newport Beach, California, 92663-3657

  • Eastern Virginia Med School /ID# 139647

    Norfolk, Virginia, 23507-1627

  • Clinical Research Partners, LL /ID# 143999

    North Chesterfield, Virginia, 23235-4722

  • Affinity Clinical Research /ID# 150980

    Oak Brook, Illinois, 60523

  • Clinical Associates of Orlando /ID# 148123

    Orlando, Florida, 32806

  • Omega Research Consultants /ID# 139648

    Orlando, Florida, 32810

  • Research Integrity, LLC /ID# 139727

    Owensboro, Kentucky, 42303-1089

  • Unified Womens Clin Research /ID# 145169

    Panama City, Florida, 32045

  • Thomas Jefferson University /ID# 139812

    Philadelphia, Pennsylvania, 19107-4414

  • Temple University Hospital /ID# 151429

    Philadelphia, Pennsylvania, 19140

  • Clinical Trials Research Svcs /ID# 139707

    Pittsburgh, Pennsylvania, 15206

  • Legacy Medical Group-Portland /ID# 148807

    Portland, Oregon, 97210

  • Unified Women's Clinical Resea /ID# 139774

    Raleigh, North Carolina, 27607

  • Clinical Trials Virginia, Inc. /ID# 139801

    Richmond, Virginia, 23225

  • Victorium Clinical Research /ID# 149630

    San Antonio, Texas, 78230

  • Discovery Clinical Trials-San Antonio /ID# 139776

    San Antonio, Texas, 78258

  • Fellows Research Alliance, Inc /ID# 139655

    Savannah, Georgia, 31406

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

    Seattle, Washington, 98105

  • Omni Fertility and Laser Insti /ID# 139836

    Shreveport, Louisiana, 71118

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

    Southfield, Michigan, 48034

  • Premier Clinical Research /ID# 148145

    Spokane, Washington, 99202

  • Houston Ctr for Clin Research /ID# 149149

    Sugar Land, Texas, 77479

  • University of Toledo /ID# 139787

    Toledo, Ohio, 43614

  • Emerson Clinical Research /ID# 147373

    Vienna, Virginia, 22182

  • Medstar Health Research Institute /ID# 145933

    Washington D.C., District of Columbia, 20010

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

    Washington D.C., District of Columbia, 20036

  • Center of Reproductive Medicin /ID# 139813

    Webster, Texas, 77598

  • Comprehensive Clinical Trials /ID# 139644

    West Palm Beach, Florida, 33409

  • Advanced RX Clinical Research /ID# 149168

    Westminster, California, 92683-4567

  • Cypress Medical Research Ctr /ID# 147116

    Wichita, Kansas, 67226

  • PMG Research of Wilmington LLC /ID# 152563

    Wilmington, North Carolina, 28401

  • Unified Women's Clinical Resea /ID# 144721

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada2 sites

  • IWK Health Center /ID# 149066

    Halifax, Nova Scotia, B3K 6R8

  • The Ottawa Hospital /ID# 148695

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Puerto Rico2 sites

  • Rodriguez-Ginorio, San Juan /ID# 139847

    San Juan, 00917

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

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Study to Evaluate the 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

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.

Being tested
Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, Placebo for Elagolix
Keywords
Elagolix, Elagolix Sodium, Heavy Uterine Bleeding, Heavy Menstrual Bleeding, Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA, Elagolix + Norethindrone Acetate, HMB
Medical subject headings
Leiomyoma, Menorrhagia

What participants receive

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

  • ElagolixDrug

    Also called ABT-620, elagolix sodium

    Film-coated tablets

  • Placebo for Estradiol/Norethindrone AcetateDrug

    Placebo capsules

  • Estradiol/Norethindrone AcetateDrug

    Also called E2/NETA

    Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.

  • Placebo for ElagolixDrug

    Film-coated placebo tablets

Study groups in NCT02654054
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)
Receives: Drug: Placebo for Estradiol/Norethindrone Acetate; Drug: Placebo for Elagolix
ElagolixExperimentalElagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Receives: Drug: Elagolix; Drug: Placebo for Estradiol/Norethindrone Acetate
Elagolix + E2/NETAExperimentalElagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Receives: Drug: Elagolix; Drug: Estradiol/Norethindrone Acetate

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 Reference Day, which is defined as the last visit date during the Treatment Period [last treatment visit date] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on 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: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

Secondary outcomes (6)

  1. Change From Baseline in MBL Volume to the Final Month

    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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.

    The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.

    Measured: Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

  2. 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.

    The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.

    Measured: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

  3. Change From Baseline in MBL Volume to Month 6

    Measured: Month 0 (Baseline), Month 6

  4. Change From Baseline in MBL Volume to Month 3

    Measured: Month 0 (Baseline), Month 3

  5. Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6

    Measured: Month 0 (Baseline), Month 6

  6. Change From Baseline in MBL Volume to Month 1

    Measured: Month 0 (Baseline), Month 1

Timeline

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

  1. First posted13 Jan 2016 (estimated)
  2. Study start22 Dec 2015
  3. Primary completion18 Jan 2018
  4. Study completion12 Dec 2018

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
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654054
Sponsor's protocol ID
M12-815
Status last verified
Jun 2020
First submitted
8 Jan 2016
Last updated
29 Jun 2020
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, Stewart EA, Jewell S, Li M, Snabes MC. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials. F S Rep. 2024 Jun 14;5(3):285-295. doi: 10.1016/j.xfre.2024.06.002. eCollection 2024 Sep.

    PubMed 39381651

  • 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

  • Stewart EA, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg EC, Gillispie-Bell V, Imudia AN, Liu R, Kim JH, Al-Hendy A. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids. J Womens Health (Larchmt). 2022 May;31(5):698-705. doi: 10.1089/jwh.2021.0152. Epub 2021 Sep 28.

    PubMed 34582715

  • Muneyyirci-Delale O, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg E, Gillispie V, Hurtado S, Kim JH, Wang A, Wang H, Stewart EA. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep. 2021 May 26;2(3):338-346. doi: 10.1016/j.xfre.2021.05.004. eCollection 2021 Sep.

    PubMed 34553161

  • Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.

    PubMed 33650259

  • Al-Hendy A, Bradley L, Owens CD, Wang H, Barnhart KT, Feinberg E, Schlaff WD, Puscheck EE, Wang A, Gillispie V, Hurtado S, Muneyyirci-Delale O, Archer DF, Carr BR, Simon JA, Stewart EA. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20.

    PubMed 32702363

  • Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.

    PubMed 31971678

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elagolix and Estradiol/Norethindrone Acetate in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by AbbVie at 96 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 5 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 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Canada, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 29 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: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6). 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 NCT02654054, which also lists 7 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 29 Jun 2020.

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