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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03986944

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:03 PM EDT

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

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

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 23, 2019 (Actual)
Primary completion
Jan 6, 2021 (Actual)
Completion
Feb 16, 2021 (Actual)
Last update posted
Apr 2, 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 2, 2025 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03986944 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →