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Uterine FibroidsPhase 3NCT02691494

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)

A Phase 3 study testing Elagolix and Estradiol/Norethindrone Acetate in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by AbbVie at 105 sites in 2 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
378 participants
Where
105 sitesin 2 countries
Study dates
3 Feb 2016to 23 Jan 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

  • 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

105 sites in 2 countries.

105 sites in 2 countries

United States103 sites

  • Paramount Research Solutions /ID# 149291

    Alpharetta, Georgia, 30005

  • Agile Clinical Research Trials /ID# 167074

    Atlanta, Georgia, 30328

  • Mount Vernon Clinical Res, LLC /ID# 144297

    Atlanta, Georgia, 30328

  • Atlanta Women's Research Inst /ID# 144303

    Atlanta, Georgia, 30342

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

    Augusta, Georgia, 30909

  • Georgia Regents University /ID# 144295

    Augusta, Georgia, 30912

  • Lotus Gynecology /ID# 149140

    Austin, Texas, 78703-1448

  • Ideal Clinical Research Inc. /ID# 149757

    Aventura, Florida, 33180

  • Baltimore Suburban Health /ID# 154638

    Baltimore, Maryland, 21208

  • Inquest Clinical Research /ID# 149755

    Baytown, Texas, 77521-2415

  • Clinical Inquest Center Ltd /ID# 148728

    Beavercreek, Ohio, 45432

  • Alabama Clinical Therapeutics, LLC /ID# 152258

    Birmingham, Alabama, 35235-3430

  • Seffner Premier Health Care, P /ID# 167480

    Brandon, Florida, 33510

  • Holston Medical Group /ID# 149763

    Bristol, Tennessee, 37620-7346

  • SUNY Downstate Medical Center /ID# 144311

    Brooklyn, New York, 11203

  • Core Healthcare Group /ID# 151016

    Cerritos, California, 90703

  • Chattanooga Medical Research /ID# 145667

    Chattanooga, Tennessee, 37404

  • University of Chicago /ID# 152257

    Chicago, Illinois, 60637-1443

  • CTI Clinical Research Center /ID# 149761

    Cincinnati, Ohio, 45212

  • The Christ Hospital /ID# 150104

    Cincinnati, Ohio, 45219

  • Olympian Clinical Research /ID# 149756

    Clearwater, Florida, 33756

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

    Covington, Louisiana, 70433

  • Texas Health Presbyterian Hosp /ID# 149142

    Dallas, Texas, 75231

  • Alpha Research Associates LLC /ID# 152471

    Dayton, Ohio, 45417

  • Choice Research, LLC /ID# 150988

    Dothan, Alabama, 36303

  • Diagnamics Inc. /ID# 152469

    Encinitas, California, 92024

  • Brown, Pearson, Guepet Gynecology /ID# 151020

    Fairhope, Alabama, 36532

  • NECCR Fall River LLC /ID# 149584

    Fall River, Massachusetts, 02720-2972

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

    Fayetteville, North Carolina, 28304

  • KO Clinical Research, LLC /ID# 144299

    Fort Lauderdale, Florida, 33316

  • Women's Health Advantage /ID# 144301

    Fort Wayne, Indiana, 46825

  • Southampton Women's Health /ID# 152325

    Franklin, Virginia, 23851

  • University of Florida /ID# 149751

    Gainesville, Florida, 32610

  • Womens Health Center /ID# 154209

    Glen Burnie, Maryland, 21063

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

    Greensboro, North Carolina, 27408

  • Pinewest Ob-Gyn, Inc. /ID# 145671

    High Point, North Carolina, 27262

  • Chattanooga Women for Women /ID# 167051

    Hixson, Tennessee, 37343-3992

  • Baylor College of Medicine /ID# 149141

    Houston, Texas, 77030-3411

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

    Houston, Texas, 77054

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

    Houston, Texas, 77058

  • BI Research Center /ID# 149143

    Houston, Texas, 77084

  • HCP Clinical Research LLC /ID# 154434

    Huntington Beach, California, 92646

  • Womens Healthcare Assoc, DBA /ID# 149762

    Idaho Falls, Idaho, 83404

  • The Jackson Clinic, PA /ID# 145670

    Jackson, Tennessee, 38305

  • Solutions Through Adv Rch /ID# 151021

    Jacksonville, Florida, 32256

  • Meridien Research /ID# 167100

    Kenneth City, Florida, 33709-3113

  • Alliance Research Centers /ID# 149752

    Laguna Hills, California, 92653-3621

  • FMC Science /ID# 151802

    Lampasas, Texas, 76550

  • Accent Clinical Trials /ID# 149753

    Las Vegas, Nevada, 89106-4017

  • Family Medical Associates /ID# 145668

    Levittown, Pennsylvania, 19056

  • University of California, Los Angeles /ID# 149760

    Los Angeles, California, 90095

  • Bluegrass Clinical Research /ID# 150103

    Louisville, Kentucky, 40291

  • Maryland Ctr for Sexual Health /ID# 149778

    Lutherville, Maryland, 21093

  • The Womens Physician Group /ID# 144317

    Memphis, Tennessee, 38104

  • Advanced Clinical Research /ID# 149767

    Meridian, Idaho, 83642

  • Mesa Obstetricians and Gynecol /ID# 149139

    Mesa, Arizona, 85209

  • Invictus Clinical Research Group,LLC /ID# 141859

    Miami, Florida, 33144

  • Precision Research Org, LLC /ID# 144335

    Miami Lakes, Florida, 33016-1501

  • Mobile, Ob-Gyn, P.C. /ID# 144294

    Mobile, Alabama, 36608

  • Access Clinical Trials, Inc. /ID# 167333

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center /ID# 149779

    Neptune City, New Jersey, 07753-4859

  • Eastern Carolina Women's Centr /ID# 144309

    New Bern, North Carolina, 28562

  • Women Under Study, LLC /ID# 144312

    New Orleans, Louisiana, 70125-1923

  • Suncoast Clinical Research /ID# 149765

    New Port Richey, Florida, 34652

  • Manhattan Medical Research /ID# 167077

    New York, New York, 10016-6023

  • Weill Cornell Medicine /ID# 149585

    New York, New York, 10032-3725

  • Tidewater Physicians for Women /ID# 144321

    Norfolk, Virginia, 23502

  • Futura Research, Inc. /ID# 149759

    Norwalk, California, 90650

  • Affinity Clinical Research /ID# 167119

    Oak Brook, Illinois, 60523

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

    Palos Heights, Illinois, 60463-1440

  • University of Pennsylvania /ID# 149586

    Philadelphia, Pennsylvania, 19104-5502

  • Clinical Research of Philadelphia, LLC /ID# 151015

    Philadelphia, Pennsylvania, 19114

  • Willowbend Health and Wellness /ID# 144318

    Plano, Texas, 75035

  • All Wmns HC of West Broward /ID# 144298

    Plantation, Florida, 33324

  • Wake Research Associates, LLC /ID# 144307

    Raleigh, North Carolina, 27612

  • Zain Research /ID# 151018

    Richland, Washington, 99352

  • Clinical Research Partners, LLC /ID# 144310

    Richmond, Virginia, 23220-4459

  • Alliance Womens Health /ID# 152468

    Richmond, Virginia, 23226-1930

  • Saginaw Valley Med Res Group /ID# 149768

    Saginaw, Michigan, 48604

  • Oncova Clinical Research, Inc. /ID# 149764

    Saint Cloud, Florida, 34769

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

    San Antonio, Texas, 78229

  • Farid Yasharpour MD Medical Co /ID# 149770

    San Fernando, California, 91340

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

    Sarasota, Florida, 34239

  • Meridian Clinical Research, LLC /ID# 149144

    Savannah, Georgia, 31406-2675

  • Virginia Mason Medical Center /ID# 149758

    Seattle, Washington, 98101

  • Gyn-Care, Inc. /ID# 149341

    Smyrna, Georgia, 30080

  • Qps-Mra, Llc /Id# 144325

    South Miami, Florida, 33143

  • Rowan University SOM /ID# 152697

    Stratford, New Jersey, 08084

  • Martin Health System Center /ID# 152263

    Stuart, Florida, 34994

  • Atlanta Gynecology Research Institute /ID# 151014

    Suwanee, Georgia, 30024-7159

  • University of South Florida /ID# 149754

    Tampa, Florida, 33612

  • Montefiore Medical Center /ID# 149582

    The Bronx, New York, 10461

  • Visions Clinical Research-Tucs /ID# 151017

    Tucson, Arizona, 85712

  • Clinical Trial Investigators /ID# 152470

    Tustin, California, 92780

  • Bayview Research Group LLC /ID# 153799

    Valley Village, California, 91607

  • Emerson Clinical Research Inst /ID# 152348

    Washington D.C., District of Columbia, 20011

  • Center of Reproductive Medicin /ID# 167235

    Webster, Texas, 77598

  • Axcess Medical Research /ID# 149769

    Wellington, Florida, 33414

  • Virtus Research Consultant,LLC /ID# 144296

    Wellington, Florida, 33414

  • The Iowa Clinic /ID# 150105

    West Des Moines, Iowa, 50266

  • Reading Hosp Clncl Trials Ofc /ID# 149583

    West Reading, Pennsylvania, 19611

  • Comprehensive Womens Care /ID# 144306

    Westerville, Ohio, 43081

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

    Wichita, Kansas, 67205

Other trials in United States

Canada2 sites

  • Medicor Research Inc. /ID# 153406

    Greater Sudbury, Ontario, P3A 1W8

  • Victory Reproductive Care /ID# 150247

    Windsor, Ontario, N8W 5R7

Other trials in Canada

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 (HMB), Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA (Elagolix + 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.

  • 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 NCT02691494
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: Baseline and 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

    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.

    Measured: Month 0 (Baseline), Month 6

  4. Change From Baseline in MBL Volume to Month 3

    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.

    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

    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.

    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 posted25 Feb 2016 (estimated)
  2. Study start3 Feb 2016
  3. Primary completion14 Feb 2018
  4. Study completion23 Jan 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
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691494
Sponsor's protocol ID
M12-817
Status last verified
Jul 2021
First submitted
22 Feb 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, 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

  • 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 105 sites in 2 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 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 105 sites in United States, 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. 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 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: 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 NCT02691494, which also lists 6 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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