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EndometriosisPhase 3NCT03986944

A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

A Phase 3 study testing 75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg) in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 112 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the… Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis
What is being tested?
75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
112 sitesin 3 countries
Study dates
23 May 2019to 16 Feb 2021
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 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The subject must have:
  • Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
  • Moderate to severe endometriosis-associated pain during the screening period.
  • Regular menstrual cycles.
  • BMI ≥ 18 kg/m2 at the screening visit.

Who cannot join

  • The subject will be excluded if she:
  • Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
  • Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
  • Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
  • Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
  • Has a history of, or known, osteoporosis or other metabolic bone disease.
  • Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Trial locations and contacts

112 sites in 3 countries.

112 sites in 3 countries

United States107 sites

  • Albuquerque Clinical Trials, Inc. / ID # 707

    Albuquerque, New Mexico, 87102

  • Atlanta Women's Research Institute, Inc. / ID # 727

    Atlanta, Georgia, 30342

  • Women Partners in Health / ID # 836

    Austin, Texas, 78705

  • Austin Area ObGyn PLLC / ID # 701

    Austin, Texas, 78758

  • Christina Sebestyen MD, P.A. dba OBGYN North / ID # 764

    Austin, Texas, 78758

  • Johns Hopkins University, School Of Medicine / ID # 816

    Baltimore, Maryland, 21205

  • Pharmasite Research Inc / ID # 838

    Baltimore, Maryland, 21208

  • Christus St. Elizabeth Gadolin Research, LLC / ID # 774

    Beaumont, Texas, 77702

  • Birmingham OBGYN / ID # 740

    Birmingham, Alabama, 35205

  • Dr. David I. Lubetkin, LLC / ID # 703

    Boca Raton, Florida, 33486

  • Helix Biomedics Clincial Research, LLC / ID # 750

    Boynton Beach, Florida, 33435

  • Seasons at Bristol / ID # 705

    Bristol, Tennessee, 37620

  • WR-ClinSearch, LLC / ID # 821

    Chattanooga, Tennessee, 37421

  • Moore Health Wellness Research Institute, LLC / ID # 795

    Chicago, Illinois, 60605

  • ClinOhio Research Services, LLC / ID # 722

    Columbus, Ohio, 43213

  • Complete Healthcare for Women / ID # 801

    Columbus, Ohio, 43213

  • HCWC dba DiscoveryClinical Trials / ID # 771

    Dallas, Texas, 75231

  • UT Southwestern Medical Center / ID # 823

    Dallas, Texas, 75390

  • Wright State Physicians / ID # 733

    Dayton, Ohio, 45409

  • Accel Research Sites, DeLand Clinical Research Unit / ID # 713

    DeLand, Florida, 32720

  • Downtown Women's Health Care / ID # 718

    Denver, Colorado, 80209

  • Universal Axon Clinical Research / ID # 769

    Doral, Florida, 33166

  • Physicians Research Options PRO / ID # 766

    Draper, Utah, 84020

  • OB/GYN Associates of Erie / ID # 706

    Erie, Pennsylvania, 16507

  • Horizon Research Group of Opelousas, LLC / ID # 757

    Eunice, Louisiana, 70535-5100

  • Providea Health Partners LLC / ID # 734

    Evergreen Park, Illinois, 60805

  • NECCR Fall River, LLC / Id # 712

    Fall River, Massachusetts, 02720

  • Carolina Institute for Clinical Research / ID # 728

    Fayetteville, North Carolina, 28304

  • Onyx Clinical Research / ID # 793

    Flint, Michigan, 48532

  • Signature Gyn Services / ID # 726

    Fort Worth, Texas, 76104

  • Hilltop OBGYN / ID # 711

    Franklin, Ohio, 45005

  • Georgetown OB/GYN / ID # 770

    Georgetown, Texas, 78626

  • Unified Women's Clinical Research - Green Valley OBGYN / ID # 719

    Greensboro, North Carolina, 27408

  • VitaLink Research - Upstate / ID # 789

    Greenville, South Carolina, 29615

  • Center for Women's Health / ID # 761

    Greenwood Village, Colorado, 80111

  • Penn State Health Milton S. Hershey Medical Center / ID # 804

    Hershey, Pennsylvania, 17033

  • Ventavia Research Group, LLC / ID # 729

    Houston, Texas, 77008

  • Vilo Research Group / ID # 709

    Houston, Texas, 77017

  • UT Health Clinical Res Ctr / ID # 828

    Houston, Texas, 77024

  • TMC Life Research, Inc. / ID # 809

    Houston, Texas, 77054

  • Join Clinical Trials / ID # 778

    Huntington Park, California, 90255

  • MacArthur OB-Gyn Research / ID # 840

    Irving, Texas, 75062

  • Clinical Neuroscience Solutions, Inc. / ID # 773

    Jacksonville, Florida, 32256

  • The Clinical Trial Center / ID # 744

    Jenkintown, Pennsylvania, 19046

  • Medical Colleagues of Texas / ID # 819

    Katy, Texas, 77450

  • University of Tennessee Medical Center / ID # 780

    Knoxville, Tennessee, 37920

  • Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732

    Lakewood, Colorado, 80228

  • FMC Science / ID # 730

    Lampasas, Texas, 76550

  • Office of Edmond Pack, MD / Id # 818

    Las Vegas, Nevada, 89113

  • Lawrence OB/GYN clinical Research, LLC / ID # 742

    Lawrenceville, New Jersey, 08648

  • Maximos OB/GYN / ID # 737

    League City, Texas, 77573

  • Lynn Institute of the Ozarks / ID # 826

    Little Rock, Arkansas, 72205

  • Applied Research Center of Arkansas / ID # 735

    Little Rock, Arkansas, 72212

  • Long Beach Clinical Trials, LLC / ID # 768

    Long Beach, California, 90806

  • Matrix Clinical Research / ID # 751

    Los Angeles, California, 90057

  • South Florida Clinical Research Institute / ID # 747

    Margate, Florida, 33063

  • Praetorian Pharmaceutical Research / ID # 739

    Marrero, Louisiana, 70072

  • DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials / ID # 803

    McAllen, Texas, 78503

  • Clinical Neuroscience Solutions, Inc / ID # 772

    Memphis, Tennessee, 38119

  • Sonara Clinical Research, LLC / ID # 720

    Meridian, Idaho, 83646

  • Mesa Obstetricians and Gyneocologists / ID # 790

    Mesa, Arizona, 85209

  • Coral Way Research / ID # 799

    Miami, Florida, 33135

  • Suncoast Research Group, LLC / ID # 756

    Miami, Florida, 33135

  • Biotech Pharmaceutical Group LLC / ID # 786

    Miami, Florida, 33155

  • La Salud Research Clinic, Inc. / ID # 824

    Miami, Florida, 33155

  • Suncoast Research Associates, LLC / ID # 760

    Miami, Florida, 33176

  • LCC Medical Research Institute / ID # 814

    Miami, Florida, 33196-1554

  • Global Health Research Center, Inc. / ID # 787

    Miami Lakes, Florida, 33016

  • Clinical Research Associates Inc / ID # 802

    Nashville, Tennessee, 37203

  • Eastern Carolina Women's Center / Id # 794

    New Bern, North Carolina, 28562

  • Women Under Study, LLC / ID # 820

    New Orleans, Louisiana, 70125

  • Clinical Trials of South Carolina / ID # 741

    North Charleston, South Carolina, 29406

  • Futura Research, Org / ID # 781

    Norwalk, California, 90650

  • Sensible Healthcare / ID # 749

    Ocoee, Florida, 34761

  • A Premier Medical Research of Florida, LLC / ID # 752

    Orange City, Florida, 32763

  • Clinical Neuroscience Solutions, Inc. / ID # 731

    Orlando, Florida, 32801

  • Omega Research Orlando, LLC / ID # 785

    Orlando, Florida, 32806-1133

  • Clinical Associates of Orlando, LLC / ID # 779

    Orlando, Florida, 32806

  • Synexus Clinical Research US, Inc. / ID # 725

    Orlando, Florida, 32806

  • National Research Institute / ID # 805

    Panorama City, California, 91402

  • DCT-AACT, LLC dba Discovery Clinical Trials / ID # 815

    Pflugerville, Texas, 78660

  • Precision Trials AZ, LLC / ID # 783

    Phoenix, Arizona, 85032

  • Physicians' Res Options - PG / ID # 833

    Pleasant Grove, Utah, 84062

  • Oregon Health & Science University / ID # 791

    Portland, Oregon, 97239

  • Unified Women's Clinical Research - Raleigh / Id # 714

    Raleigh, North Carolina, 27607

  • Clinical Research Partners, LLC / ID # 715

    Richmond, Virginia, 23225

  • Clinical Research Partners, LLC / ID # 775

    Richmond, Virginia, 23235

  • CMEP/CMU health / ID # 812

    Saginaw, Michigan, 48602

  • Valley OBGYN / ID # 704

    Saginaw, Michigan, 48602

  • Saginaw Valley Medical Research Group, LLC / ID # 743

    Saginaw, Michigan, 48604

  • Wasatch Clinical Research / ID # 746

    Salt Lake City, Utah, 84107

  • Highland Clinical Research / ID # 708

    Salt Lake City, Utah, 84124

  • Precision Research Institute / ID # 792

    San Diego, California, 92114

  • MD Strategies Research Centers / ID # 765

    San Diego, California, 92119

  • Physician Care Clinical Research LLC / ID # 810

    Sarasota, Florida, 34239

  • Northeast Clinical Research of San Antonio, LLC / ID # 710

    Schertz, Texas, 78154

  • Seattle Women's: Health, Research, Gynecology / ID # 702

    Seattle, Washington, 98105

  • Seattle Reproductive Medicine / ID # 811

    Seattle, Washington, 98109

  • VitaLink Research Spartanburg / ID # 753

    Spartanburg, South Carolina, 29303

  • University of South Florida / ID # 738

    Tampa, Florida, 33606

  • GCP Clinical Research, LLC / ID # 825

    Tampa, Florida, 33609

  • Continental Clinical Solutions, LLC / ID # 777

    Towson, Maryland, 21204

  • Quality of LIfe Medical & Research Center, LLC / ID # 813

    Tucson, Arizona, 85712

  • Visions Clinical Research-Tucson / ID # 754

    Tucson, Arizona, 85712

  • Tidewater Clinical Research The Group for Women / ID # 716

    Virginia Beach, Virginia, 23456

  • Cypress Medical Research Center, LLC / ID # 755

    Wichita, Kansas, 67226

  • Carolina Medical Trials, LLC / ID # 788

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada3 sites

  • McMaster University Medical Centre / ID # 870

    Hamilton, Ontario, L8S 4K1

  • CARe Clinic / ID # 872

    Red Deer, Alberta, T4N 6V7

  • Victory Reproductive Care / ID # 873

    Windsor, Ontario, N8N C52

Other trials in Canada

Puerto Rico2 sites

  • Ponce Medical SChool Foundation Inc./ CAIMED Center / ID # 891

    Ponce, 00716

  • Puerto Rico Medical Research Inc. / ID # 890

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

Read the detailed description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.

Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Conditions
Endometriosis
Being tested
75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg), Placebo tablet to match 75 mg linzagolix tablet, Placebo tablet to match 200 mg linzagolix tablet
Keywords
Dysmenorrhea, Dyspareunia, Dyschezia, Non-menstrual pelvic pain
Medical subject headings
Endometriosis, Dysmenorrhea, Dyspareunia, Constipation

What participants receive

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

  • 75 mg linzagolix tabletDrug

    For oral administration once daily

  • 200 mg linzagolix tabletDrug

    For oral administration once daily

  • Add-back capsule (E2 1 mg / NETA 0.5 mg)Drug

    For oral administration once daily

  • Placebo tablet to match 75 mg linzagolix tabletDrug

    For oral administration once daily

  • Placebo tablet to match 200 mg linzagolix tabletDrug

    For oral administration once daily

  • Placebo capsule to match Add-back capsuleDrug

    For oral administration once daily

Study groups in NCT03986944
Study groupRoleWhat they receive
Linzagolix 75 mgExperimentalNot described
Receives: Drug: 75 mg linzagolix tablet; Drug: Placebo tablet to match 200 mg linzagolix tablet; Drug: Placebo capsule to match Add-back capsule
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)ExperimentalNot described
Receives: Drug: 200 mg linzagolix tablet; Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg); Drug: Placebo tablet to match 75 mg linzagolix tablet
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo tablet to match 75 mg linzagolix tablet; Drug: Placebo tablet to match 200 mg linzagolix tablet; Drug: Placebo capsule to match Add-back capsule

What is being measured

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

  1. Dysmenorrhea

    Change at Month 3 from baseline in the mean daily assessment of dysmenorrhea (DYS) measured on a 4-point Verbal Rating Scale (VRS) using an electronicdiary

    • The 4-point VRS scale for DYS ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain).
    • A negative change in scores would be indicative of an improvement in the pain of DYS.

    Measured: Baseline to Month 3

  2. Non-menstrual Pelvic Pain

    Change at Month 3 from baseline in the mean daily assessment of non-menstrual pelvic pain (NMPP) measured on a 4-point Verbal Rating Scale (VRS) using anelectronic diary

    • The 4-point VRS scale for NMPP ranges from 0 to 3 (0: No pain; 1: Mild pain; 2: Moderate pain; 3: Severe pain).
    • A negative change in scores would be indicative of an improvement in the NMPP.

    Measured: Baseline to Month 3

Timeline

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

  1. First posted14 Jun 2019
  2. Study start23 May 2019
  3. Primary completion6 Jan 2021
  4. Study completion16 Feb 2021

Why it stopped: Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.

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
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986944
Sponsor's protocol ID
18-OBE2109-002
Status last verified
May 2022
First submitted
6 Jun 2019
Last updated
2 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 75 mg linzagolix tablet, 200 mg linzagolix tablet and Add-back capsule (E2 1 mg / NETA 0.5 mg) in people with Endometriosis, run by Kissei Pharmaceutical Co., Ltd. at 112 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 7 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: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 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 Oct 2024). 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?

Dysmenorrhea (time frame: Baseline to Month 3). The study lists 2 primary outcomes in all. 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 NCT03986944.

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 2 Apr 2025.

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