A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
Public ClinicalTrials.gov record NCT03986944. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Study identification
- NCT ID
- NCT03986944
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Industry
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Interventions
- 75 mg linzagolix tablet 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 Drug
- Placebo tablet to match 200 mg linzagolix tablet Drug
- Placebo capsule to match Add-back capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2019
- Primary completion
- Jan 5, 2021
- Completion
- Feb 15, 2021
- Last update posted
- Apr 1, 2025
2019 – 2021
United States locations
- U.S. sites
- 107
- U.S. states
- 27
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham OBGYN / ID # 740 | Birmingham | Alabama | 35205 | — |
| Mesa Obstetricians and Gyneocologists / ID # 790 | Mesa | Arizona | 85209 | — |
| Precision Trials AZ, LLC / ID # 783 | Phoenix | Arizona | 85032 | — |
| Quality of LIfe Medical & Research Center, LLC / ID # 813 | Tucson | Arizona | 85712 | — |
| Visions Clinical Research-Tucson / ID # 754 | Tucson | Arizona | 85712 | — |
| Lynn Institute of the Ozarks / ID # 826 | Little Rock | Arkansas | 72205 | — |
| Applied Research Center of Arkansas / ID # 735 | Little Rock | Arkansas | 72212 | — |
| Join Clinical Trials / ID # 778 | Huntington Park | California | 90255 | — |
| Long Beach Clinical Trials, LLC / ID # 768 | Long Beach | California | 90806 | — |
| Matrix Clinical Research / ID # 751 | Los Angeles | California | 90057 | — |
| Futura Research, Org / ID # 781 | Norwalk | California | 90650 | — |
| National Research Institute / ID # 805 | Panorama City | California | 91402 | — |
| Precision Research Institute / ID # 792 | San Diego | California | 92114 | — |
| MD Strategies Research Centers / ID # 765 | San Diego | California | 92119 | — |
| Downtown Women's Health Care / ID # 718 | Denver | Colorado | 80209 | — |
| Center for Women's Health / ID # 761 | Greenwood Village | Colorado | 80111 | — |
| Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732 | Lakewood | Colorado | 80228 | — |
| Dr. David I. Lubetkin, LLC / ID # 703 | Boca Raton | Florida | 33486 | — |
| Helix Biomedics Clincial Research, LLC / ID # 750 | Boynton Beach | Florida | 33435 | — |
| Accel Research Sites, DeLand Clinical Research Unit / ID # 713 | DeLand | Florida | 32720 | — |
| Universal Axon Clinical Research / ID # 769 | Doral | Florida | 33166 | — |
| Clinical Neuroscience Solutions, Inc. / ID # 773 | Jacksonville | Florida | 32256 | — |
| South Florida Clinical Research Institute / ID # 747 | Margate | Florida | 33063 | — |
| 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 | — |
| 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 | — |
| Physician Care Clinical Research LLC / ID # 810 | Sarasota | Florida | 34239 | — |
| University of South Florida / ID # 738 | Tampa | Florida | 33606 | — |
| GCP Clinical Research, LLC / ID # 825 | Tampa | Florida | 33609 | — |
| Atlanta Women's Research Institute, Inc. / ID # 727 | Atlanta | Georgia | 30342 | — |
| Sonara Clinical Research, LLC / ID # 720 | Meridian | Idaho | 83646 | — |
| Moore Health Wellness Research Institute, LLC / ID # 795 | Chicago | Illinois | 60605 | — |
| Providea Health Partners LLC / ID # 734 | Evergreen Park | Illinois | 60805 | — |
| Cypress Medical Research Center, LLC / ID # 755 | Wichita | Kansas | 67226 | — |
| Horizon Research Group of Opelousas, LLC / ID # 757 | Eunice | Louisiana | 70535-5100 | — |
| Praetorian Pharmaceutical Research / ID # 739 | Marrero | Louisiana | 70072 | — |
| Women Under Study, LLC / ID # 820 | New Orleans | Louisiana | 70125 | — |
| Johns Hopkins University, School Of Medicine / ID # 816 | Baltimore | Maryland | 21205 | — |
| Pharmasite Research Inc / ID # 838 | Baltimore | Maryland | 21208 | — |
| Continental Clinical Solutions, LLC / ID # 777 | Towson | Maryland | 21204 | — |
| NECCR Fall River, LLC / Id # 712 | Fall River | Massachusetts | 02720 | — |
| Onyx Clinical Research / ID # 793 | Flint | Michigan | 48532 | — |
| 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 | — |
| Office of Edmond Pack, MD / Id # 818 | Las Vegas | Nevada | 89113 | — |
| Lawrence OB/GYN clinical Research, LLC / ID # 742 | Lawrenceville | New Jersey | 08648 | — |
| Albuquerque Clinical Trials, Inc. / ID # 707 | Albuquerque | New Mexico | 87102 | — |
| Carolina Institute for Clinical Research / ID # 728 | Fayetteville | North Carolina | 28304 | — |
| Unified Women's Clinical Research - Green Valley OBGYN / ID # 719 | Greensboro | North Carolina | 27408 | — |
| Eastern Carolina Women's Center / Id # 794 | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Research - Raleigh / Id # 714 | Raleigh | North Carolina | 27607 | — |
| Carolina Medical Trials, LLC / ID # 788 | Winston-Salem | North Carolina | 27103 | — |
| ClinOhio Research Services, LLC / ID # 722 | Columbus | Ohio | 43213 | — |
| Complete Healthcare for Women / ID # 801 | Columbus | Ohio | 43213 | — |
| Wright State Physicians / ID # 733 | Dayton | Ohio | 45409 | — |
| Hilltop OBGYN / ID # 711 | Franklin | Ohio | 45005 | — |
| Oregon Health & Science University / ID # 791 | Portland | Oregon | 97239 | — |
| OB/GYN Associates of Erie / ID # 706 | Erie | Pennsylvania | 16507 | — |
| Penn State Health Milton S. Hershey Medical Center / ID # 804 | Hershey | Pennsylvania | 17033 | — |
| The Clinical Trial Center / ID # 744 | Jenkintown | Pennsylvania | 19046 | — |
| VitaLink Research - Upstate / ID # 789 | Greenville | South Carolina | 29615 | — |
| Clinical Trials of South Carolina / ID # 741 | North Charleston | South Carolina | 29406 | — |
| VitaLink Research Spartanburg / ID # 753 | Spartanburg | South Carolina | 29303 | — |
| Seasons at Bristol / ID # 705 | Bristol | Tennessee | 37620 | — |
| WR-ClinSearch, LLC / ID # 821 | Chattanooga | Tennessee | 37421 | — |
| University of Tennessee Medical Center / ID # 780 | Knoxville | Tennessee | 37920 | — |
| Clinical Neuroscience Solutions, Inc / ID # 772 | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates Inc / ID # 802 | Nashville | Tennessee | 37203 | — |
| 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 | — |
| Christus St. Elizabeth Gadolin Research, LLC / ID # 774 | Beaumont | Texas | 77702 | — |
| HCWC dba DiscoveryClinical Trials / ID # 771 | Dallas | Texas | 75231 | — |
| UT Southwestern Medical Center / ID # 823 | Dallas | Texas | 75390 | — |
| Signature Gyn Services / ID # 726 | Fort Worth | Texas | 76104 | — |
| Georgetown OB/GYN / ID # 770 | Georgetown | Texas | 78626 | — |
| 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 | — |
| MacArthur OB-Gyn Research / ID # 840 | Irving | Texas | 75062 | — |
| Medical Colleagues of Texas / ID # 819 | Katy | Texas | 77450 | — |
| FMC Science / ID # 730 | Lampasas | Texas | 76550 | — |
| Maximos OB/GYN / ID # 737 | League City | Texas | 77573 | — |
| DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials / ID # 803 | McAllen | Texas | 78503 | — |
| DCT-AACT, LLC dba Discovery Clinical Trials / ID # 815 | Pflugerville | Texas | 78660 | — |
| Northeast Clinical Research of San Antonio, LLC / ID # 710 | Schertz | Texas | 78154 | — |
| Physicians Research Options PRO / ID # 766 | Draper | Utah | 84020 | — |
| Physicians' Res Options - PG / ID # 833 | Pleasant Grove | Utah | 84062 | — |
| Wasatch Clinical Research / ID # 746 | Salt Lake City | Utah | 84107 | — |
| Highland Clinical Research / ID # 708 | Salt Lake City | Utah | 84124 | — |
| Clinical Research Partners, LLC / ID # 715 | Richmond | Virginia | 23225 | — |
| Clinical Research Partners, LLC / ID # 775 | Richmond | Virginia | 23235 | — |
| Tidewater Clinical Research The Group for Women / ID # 716 | Virginia Beach | Virginia | 23456 | — |
| Seattle Women's: Health, Research, Gynecology / ID # 702 | Seattle | Washington | 98105 | — |
| Seattle Reproductive Medicine / ID # 811 | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03986944, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 1, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03986944 live on ClinicalTrials.gov.