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AzTrials

Heavy Menstrual BleedingPhase 3NCT03271489

Long-Term Safety Study 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 (E2/NETA) in people with Heavy Menstrual Bleeding and Uterine Fibroids, run by AbbVie at 157 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 randomized multicenter phase 3b study seeks to evaluate the safety of elagolix 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 50 years, women only
Conditions the study is for
Heavy Menstrual Bleeding, Uterine Fibroids
What is being tested?
Elagolix and Estradiol /norethindrone acetate (E2/NETA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
478 participants
Where
157 sitesin 2 countries
Study dates
13 Sep 2017to 28 Jun 2024
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant is a premenopausal female at the time of Screening.
  • Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)].
  • Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method.
  • Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose.
  • Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Who cannot join

  • Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder.
  • Participant has history of osteoporosis or other metabolic bone disease.
  • Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
  • Participant 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 intra-articular injectable (for occasional use) corticosteroids are allowed.

Trial locations and contacts

157 sites in 2 countries.

157 sites in 2 countries

United States155 sites

  • Lovelace Scientific Resources /ID# 163644

    Albuquerque, New Mexico, 87108

  • Bosque Women's Care /ID# 162606

    Albuquerque, New Mexico, 87109

  • Journey Medical Research Insti /ID# 160958

    Alpharetta, Georgia, 30005

  • Paramount Research Solutions /ID# 161557

    Alpharetta, Georgia, 30005

  • AGILE Clinical Research Trials /ID# 160941

    Atlanta, Georgia, 30328-5532

  • Mount Vernon Clinical Res, LLC /ID# 161491

    Atlanta, Georgia, 30328

  • Atlanta Women's Research Institute /ID# 160844

    Atlanta, Georgia, 30342

  • Medisense Inc /ID# 161494

    Atlanta, Georgia, 30363

  • OBGYN North /ID# 203580

    Austin, Texas, 78758-5444

  • Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542

    Austin, Texas, 78758-5653

  • Duplicate_Great Lakes Research Group, Inc. /ID# 161511

    Bay City, Michigan, 48602

  • Clinical Inquest Center Ltd /ID# 160892

    Beavercreek, Ohio, 45431-2573

  • Alabama Clinical Therapeutics /ID# 160835

    Birmingham, Alabama, 35235-3430

  • Alabama Clinical Therapeutics /ID# 160927

    Birmingham, Alabama, 35235-3430

  • Bingham Memorial Hospital /ID# 201130

    Blackfoot, Idaho, 83221

  • Women's Health Partners /ID# 203577

    Boca Raton, Florida, 33433-7041

  • David Lubetkin MD LLC /ID# 203578

    Boca Raton, Florida, 33486-2269

  • Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910

    Brandon, Florida, 33510-3107

  • SUNY Downstate Medical Center /ID# 160922

    Brooklyn, New York, 11203

  • Duplicate_Core Healthcare Group /ID# 160858

    Cerritos, California, 90703

  • Women's Health Practice, LLC /ID# 161553

    Champaign, Illinois, 61820

  • DJL Clinical Research, PLLC /ID# 161548

    Charlotte, North Carolina, 28211

  • Univ of Virgnia Medical center /ID# 166283

    Charlottesville, Virginia, 22908-0816

  • Duplicate_Chattanooga Medical Research /ID# 160885

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch /ID# 160887

    Chattanooga, Tennessee, 37421-1605

  • Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118

    Chicago, Illinois, 60605-2168

  • Duplicate_University of Chicago /ID# 162667

    Chicago, Illinois, 60637

  • Duplicate_CTI Clinical Research Center /ID# 160942

    Cincinnati, Ohio, 45212

  • Univ Hosp Cleveland /ID# 160953

    Cleveland, Ohio, 44106

  • Vista Clinical Research /ID# 160946

    Columbia, South Carolina, 29201

  • Central Ohio Clinical Research /ID# 201162

    Columbus, Ohio, 43213-3399

  • Duplicate_Optimed Research /ID# 165600

    Columbus, Ohio, 43235

  • Clinical Trials Management, LLC - Covington /ID# 160838

    Covington, Louisiana, 70433

  • Clinical Trials Management, LLC - Covington /ID# 160893

    Covington, Louisiana, 70433

  • Discovery Clinical Trials -HCWC /ID# 161543

    Dallas, Texas, 75230-2571

  • Duplicate_The University of Texas Southwestern Medical Center /ID# 161496

    Dallas, Texas, 75390-8575

  • Omega Research Maitland, LLC /ID# 160857

    DeBary, Florida, 32713-2260

  • Midland Florida Clinical Research Center /ID# 161487

    DeLand, Florida, 32720-0920

  • Wayne State University /ID# 160944

    Detroit, Michigan, 48201-2013

  • Choice Research, LLC /ID# 161498

    Dothan, Alabama, 36303

  • Carolina Women's Research and Wellness Center /ID# 160914

    Durham, North Carolina, 27713-7512

  • Diagnamics Inc. /ID# 160950

    Encinitas, California, 92024

  • HRC Fertility /ID# 161493

    Encino, California, 91436

  • OB/GYN Associates of Erie /ID# 161541

    Erie, Pennsylvania, 16507-1423

  • Southern Women's Specialists PC /ID# 161531

    Fairhope, Alabama, 36532-3029

  • Exordia Medical Research, Inc /ID# 160853

    Fall River, Massachusetts, 02723

  • KO Clinical Research, LLC /ID# 160928

    Fort Lauderdale, Florida, 33316

  • Women's Health Advantage /ID# 161537

    Fort Wayne, Indiana, 46825

  • Baylor Scott & White /ID# 161515

    Fort Worth, Texas, 76104-4110

  • Willowbend Health and Wellness - Frisco /ID# 160954

    Frisco, Texas, 75035

  • SC Clinical Research /ID# 164395

    Garden Grove, California, 92844

  • Penn State University and Milton S. Hershey Medical Center /ID# 160896

    Hershey, Pennsylvania, 17033

  • Sweet Hope Research Specialty Inc /ID# 163522

    Hialeah, Florida, 33016-1897

  • The Ob/Gyn Center /ID# 165928

    Houston, Texas, 77030

  • Precision Research Institute, LLC /ID# 161554

    Houston, Texas, 77036

  • The Woman's Hospital of Texas /ID# 160959

    Houston, Texas, 77054

  • Centex Studies, Inc /ID# 163858

    Houston, Texas, 77058-2705

  • Centex Studies, Inc. - Houston /ID# 160917

    Houston, Texas, 77058

  • UAG Innovation Women Research, /ID# 167415

    Houston, Texas, 77074

  • America's Adv. Wellness Center /ID# 167548

    Houston, Texas, 77080

  • Duplicate_Duplicate_Marvel Clinical Research /ID# 167297

    Huntington Beach, California, 92647

  • E Squared Research /ID# 163645

    Huntsville, Alabama, 35801

  • Leavitt Womens Healthcare /ID# 163419

    Idaho Falls, Idaho, 83404

  • Womens Healthcare Assoc, DBA /ID# 160933

    Idaho Falls, Idaho, 83404

  • The Jackson Clinic, PA /ID# 162496

    Jackson, Tennessee, 38305

  • Solutions Through Adv Rch /ID# 160935

    Jacksonville, Florida, 32256

  • Grossmont Ctr Clin Research /ID# 165120

    La Mesa, California, 91942

  • Altus Research, Inc /ID# 160912

    Lake Worth, Florida, 33461

  • FMC Science /ID# 160886

    Lampasas, Texas, 76550

  • Excel Clinical Research /ID# 165588

    Las Vegas, Nevada, 89109

  • Office of Edmond E. Pack, MD /ID# 162604

    Las Vegas, Nevada, 89113

  • Private practice: Dr. Rex G. Mabey JR /ID# 160915

    Las Vegas, Nevada, 89128

  • Olympia Clinical Trials /ID# 201562

    Los Angeles, California, 90036-4667

  • National Research Institute /ID# 160952

    Los Angeles, California, 90057

  • Bluegrass Clinical Research /ID# 163485

    Louisville, Kentucky, 40291-1988

  • Wellington Anti-Aging Centre /ID# 203540

    Loxahatchee Groves, Florida, 33470-4937

  • Duplicate_Northwell Health System - Manhasset /ID# 201058

    Manhasset, New York, 11030-3816

  • South Florida Wellness & Clinic /ID# 161535

    Margate, Florida, 33063

  • Praetorian Pharmaceutical Research /ID# 161532

    Marrero, Louisiana, 70072

  • Research Memphis Associates, LLC /ID# 160939

    Memphis, Tennessee, 38119-3895

  • Sonora Clinical Research /ID# 167610

    Meridian, Idaho, 83646-1144

  • Mesa Obstetricians and Gynecologists /ID# 160955

    Mesa, Arizona, 85209

  • Invictus Clinical Research Group,LLC /ID# 160925

    Miami, Florida, 33144

  • Healthcare Clinical Data, Inc /ID# 160888

    Miami, Florida, 33161

  • Palmetto Professional Research /ID# 161442

    Miami, Florida, 33172

  • Vista Health Research, LLC /ID# 163044

    Miami, Florida, 33176-1032

  • Duplicate_Precision Research Organization /ID# 161522

    Miami Lakes, Florida, 33016-1501

  • Ocean Blue Medical Research Center, Inc /ID# 161549

    Miami Springs, Florida, 33166

  • Hilltop Obstetrics & Gynecology /ID# 203576

    Middletown, Ohio, 45005-5200

  • Salom Tangir, LLC /ID# 162542

    Miramar, Florida, 33027

  • Women's Health Alliance of Mobile /ID# 161443

    Mobile, Alabama, 36604-1410

  • Mobile, OBGYN P.C. /ID# 161530

    Mobile, Alabama, 36608

  • Futura Research, Org /ID# 160924

    Montebello, California, 90640

  • Asr, Llc /Id# 162179

    Nampa, Idaho, 83687

  • Jersey Shore University Medical Center /ID# 160916

    Neptune City, New Jersey, 07753-4859

  • Ochsner Baptist Medical Centre /ID# 161507

    New Orleans, Louisiana, 70115

  • Women Under Study, LLC /ID# 163990

    New Orleans, Louisiana, 70125-1923

  • Advanced Research Institute, Inc /ID# 163748

    New Port Richey, Florida, 34653

  • Columbia Univ Medical Center /ID# 161519

    New York, New York, 10032-3725

  • Eastern Virginia Med School /ID# 160856

    Norfolk, Virginia, 23507-1627

  • Clinical Research Partners /ID# 160929

    North Chesterfield, Virginia, 23235

  • Clinical Research Partners /ID# 160948

    North Chesterfield, Virginia, 23235

  • California Medical Research Associates /ID# 161481

    Northridge, California, 91324

  • Alliance for Multispecialty Research, LLC /ID# 160932

    Oak Brook, Illinois, 60523

  • A Premier Medical Research of FL /ID# 201882

    Orange City, Florida, 32763-2833

  • Hamburg Regional Gynecology Gr /ID# 161427

    Orchard Park, New York, 14127

  • Clinical Associates of Orlando /ID# 160889

    Orlando, Florida, 32819-8900

  • Advances in Health, Inc. /ID# 160930

    Pearland, Texas, 77854

  • University of Pennsylvania /ID# 160936

    Philadelphia, Pennsylvania, 19104-5502

  • DUP_Thomas Jefferson University /ID# 200304

    Philadelphia, Pennsylvania, 19107

  • ClinRx Research, LLC /ID# 201170

    Plano, Texas, 75024-5280

  • Oregon Medical Research Center /ID# 161514

    Portland, Oregon, 97239

  • Unified Women's Clinical Resea /ID# 163014

    Raleigh, North Carolina, 27607

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490

    Raleigh, North Carolina, 27612

  • Clinical Trials Virginia, Inc. /ID# 160943

    Richmond, Virginia, 23225

  • Northern California Research /ID# 161561

    Sacramento, California, 95821-2640

  • Valley OB-Gyn Clinic - Saginaw /ID# 203579

    Saginaw, Michigan, 48602-4323

  • Saginaw Valley Med Res Group /ID# 160840

    Saginaw, Michigan, 48604

  • Oncova Clinical Research, Inc. /ID# 160937

    Saint Cloud, Florida, 34769

  • Clinical Trials of Texas, Inc /ID# 161510

    San Antonio, Texas, 78229

  • VIP Trials /ID# 161546

    San Antonio, Texas, 78230

  • Precision Research Institute - San Diego /ID# 163069

    San Diego, California, 92114-3643

  • MD Strategies Research Centers /ID# 161544

    San Diego, California, 92119

  • Health care Affiliates Medical Group /ID# 163324

    Santa Ana, California, 92704

  • Physician Care Clin. Res., LLC /ID# 161547

    Sarasota, Florida, 34239

  • Womens & Family Care, LLC dba /ID# 160890

    Shawnee Mission, Kansas, 66218

  • Willis-Knighton Pediatric GI S /ID# 161534

    Shreveport, Louisiana, 71118

  • Alta California Medical Group /ID# 163564

    Simi Valley, California, 93065

  • VitaLink Research-Spartanburg /ID# 164592

    Spartanburg, South Carolina, 29303

  • Quad Clinical Research, LLC /ID# 200943

    St Louis, Missouri, 63109

  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913

    St. Petersburg, Florida, 33709-3113

  • Treasure Coast Research /ID# 161824

    Stuart, Florida, 34996

  • Specialists for Women /ID# 201129

    Suffolk, Virginia, 23434-8151

  • Houston Ctr for Clin Research /ID# 160837

    Sugar Land, Texas, 77479

  • Discovery Clinical Research /ID# 160891

    Sunrise, Florida, 33324

  • Precision Clinical Research /ID# 165377

    Sunrise, Florida, 33351-7311

  • Duplicate_Atlanta Gynecology Research Institute /ID# 160851

    Suwanee, Georgia, 30024-7159

  • GCP Clinical Research, LLC /ID# 164593

    Tampa, Florida, 33609-4044

  • University of South Florida- Neuroscience Institute /ID# 160960

    Tampa, Florida, 33613

  • Jedidiah Clinical Research /ID# 167114

    Tampa, Florida, 33617

  • University of Toledo /ID# 160923

    Toledo, Ohio, 43614

  • Noble Clinical Research /ID# 166949

    Tucson, Arizona, 85704

  • Vision's Clinical Research-Tucson /ID# 161508

    Tucson, Arizona, 85712

  • Eclipse Clinical Research /ID# 161516

    Tucson, Arizona, 85745

  • The Univ Texas HSC at Tyler /ID# 161533

    Tyler, Texas, 75708

  • Upland Clinical Research /ID# 164528

    Upland, California, 91786-4027

  • Bayview Research Group LLC /ID# 161484

    Valley Village, California, 91607

  • Tidewater Clinical Research /ID# 160949

    Virginia Beach, Virginia, 23456

  • Emerson Clinical Research Inst /ID# 162181

    Washington D.C., District of Columbia, 20011

  • James A. Simon, MD, PC /ID# 160931

    Washington D.C., District of Columbia, 20036

  • Center of Reproductive Medicine /ID# 162498

    Webster, Texas, 77598

  • Virtus Research Consultants, LLC /ID# 160855

    Wellington, Florida, 33414

  • Comprehensive Clinical Trials LLC /ID# 161479

    West Palm Beach, Florida, 33409

  • Advanced RX Clinical Research /ID# 161599

    Westminster, California, 92683-4567

  • Unified Women's Clinical Resea /ID# 160957

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Henry A. Rodriguez Ginorio, MD /ID# 160861

    San Juan, 00917-5022

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

This randomized multicenter phase 3b study seeks to evaluate the 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 was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Read the detailed description

478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups:

  1. Elagolix 300 mg twice daily (BID) plus estradiol 1.0 mg/norethindrone acetate 0.5 mg (E2/NETA) once daily (QD) for 48 months, followed by 12 months PTFU
  2. Placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA QD for 36 months, followed by 12 months PTFU

This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).

Being tested
Elagolix, Estradiol /norethindrone acetate (E2/NETA), E2/NETA Placebo, Elagolix Placebo
Keywords
Elagolix Sodium, Heavy Menstrual Bleeding (HMB), Heavy Uterine Bleeding, Leiomyomata, Menorrhagia, Elagolix + Norethindrone Acetate, Elagolix + E2/NETA, Elagolix, Safety, Efficacy
Medical subject headings
Menorrhagia, Leiomyoma

What participants receive

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

  • ElagolixDrug

    Film-coated 300 mg tablets

  • Estradiol /norethindrone acetate (E2/NETA)Drug

    Estradiol 1 mg/norethindrone acetate 0.5 mg capsules

  • E2/NETA PlaceboOther

    Placebo capsules

  • Elagolix PlaceboOther

    Film-coated placebo tablets

Study groups in NCT03271489
Study groupRoleWhat they receive
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)ExperimentalNot described
Receives: Drug: Elagolix; Drug: Estradiol /norethindrone acetate (E2/NETA)
PlaceboPlacebo comparatorNot described
Receives: Other: E2/NETA Placebo; Other: Elagolix Placebo

What is being measured

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

  1. Number of Participants With Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.

    Measured: Baseline to 60 months

Secondary outcomes (1)

  1. Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment

    Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.

    Measured: Baseline through Month 60

Timeline

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

  1. First posted5 Sep 2017
  2. Study start13 Sep 2017
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

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
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03271489
Sponsor's protocol ID
M16-283
Status last verified
Jul 2025
First submitted
31 Aug 2017
Last updated
22 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elagolix and Estradiol /norethindrone acetate (E2/NETA) in people with Heavy Menstrual Bleeding and Uterine Fibroids, run by AbbVie at 157 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, 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 22 Jul 2025). 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?

Number of Participants With Adverse Events (AEs) (time frame: Baseline to 60 months). 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 NCT03271489.

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 22 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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