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

PHASE3TerminatedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 23, 2019

Primary Completion Date

January 6, 2021

Study Completion Date

February 16, 2021

Conditions
Endometriosis
Interventions
DRUG

75 mg linzagolix tablet

For oral administration once daily

DRUG

200 mg linzagolix tablet

For oral administration once daily

DRUG

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

For oral administration once daily

DRUG

Placebo tablet to match 75 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo tablet to match 200 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo capsule to match Add-back capsule

For oral administration once daily

Trial Locations (112)

16507

OB/GYN Associates of Erie / ID # 706, Erie

17033

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

19046

The Clinical Trial Center / ID # 744, Jenkintown

21204

Continental Clinical Solutions, LLC / ID # 777, Towson

21205

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

21208

Pharmasite Research Inc / ID # 838, Baltimore

23225

Clinical Research Partners, LLC / ID # 715, Richmond

23235

Clinical Research Partners, LLC / ID # 775, Richmond

23456

Tidewater Clinical Research The Group for Women / ID # 716, Virginia Beach

27103

Carolina Medical Trials, LLC / ID # 788, Winston-Salem

27408

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

27607

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

28304

Carolina Institute for Clinical Research / ID # 728, Fayetteville

28562

Eastern Carolina Women's Center / Id # 794, New Bern

29303

VitaLink Research Spartanburg / ID # 753, Spartanburg

29406

Clinical Trials of South Carolina / ID # 741, North Charleston

29615

VitaLink Research - Upstate / ID # 789, Greenville

30342

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

32256

Clinical Neuroscience Solutions, Inc. / ID # 773, Jacksonville

32720

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

32763

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

32801

Clinical Neuroscience Solutions, Inc. / ID # 731, Orlando

32806

Clinical Associates of Orlando, LLC / ID # 779, Orlando

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

33016

Global Health Research Center, Inc. / ID # 787, Miami Lakes

33063

South Florida Clinical Research Institute / ID # 747, Margate

33135

Coral Way Research / ID # 799, Miami

Suncoast Research Group, LLC / ID # 756, Miami

33155

Biotech Pharmaceutical Group LLC / ID # 786, Miami

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

33166

Universal Axon Clinical Research / ID # 769, Doral

33176

Suncoast Research Associates, LLC / ID # 760, Miami

33435

Helix Biomedics Clincial Research, LLC / ID # 750, Boynton Beach

33486

Dr. David I. Lubetkin, LLC / ID # 703, Boca Raton

33606

University of South Florida / ID # 738, Tampa

33609

GCP Clinical Research, LLC / ID # 825, Tampa

34239

Physician Care Clinical Research LLC / ID # 810, Sarasota

34761

Sensible Healthcare / ID # 749, Ocoee

35205

Birmingham OBGYN / ID # 740, Birmingham

37203

Clinical Research Associates Inc / ID # 802, Nashville

37421

WR-ClinSearch, LLC / ID # 821, Chattanooga

37620

Seasons at Bristol / ID # 705, Bristol

37920

University of Tennessee Medical Center / ID # 780, Knoxville

38119

Clinical Neuroscience Solutions, Inc / ID # 772, Memphis

43213

ClinOhio Research Services, LLC / ID # 722, Columbus

Complete Healthcare for Women / ID # 801, Columbus

45005

Hilltop OBGYN / ID # 711, Franklin

45409

Wright State Physicians / ID # 733, Dayton

48532

Onyx Clinical Research / ID # 793, Flint

48602

CMEP/CMU health / ID # 812, Saginaw

Valley OBGYN / ID # 704, Saginaw

48604

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

60605

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

60805

Providea Health Partners LLC / ID # 734, Evergreen Park

67226

Cypress Medical Research Center, LLC / ID # 755, Wichita

70072

Praetorian Pharmaceutical Research / ID # 739, Marrero

70125

Women Under Study, LLC / ID # 820, New Orleans

72205

Lynn Institute of the Ozarks / ID # 826, Little Rock

72212

Applied Research Center of Arkansas / ID # 735, Little Rock

75062

MacArthur OB-Gyn Research / ID # 840, Irving

75231

HCWC dba DiscoveryClinical Trials / ID # 771, Dallas

75390

UT Southwestern Medical Center / ID # 823, Dallas

76104

Signature Gyn Services / ID # 726, Fort Worth

76550

FMC Science / ID # 730, Lampasas

77008

Ventavia Research Group, LLC / ID # 729, Houston

77017

Vilo Research Group / ID # 709, Houston

77024

UT Health Clinical Res Ctr / ID # 828, Houston

77054

TMC Life Research, Inc. / ID # 809, Houston

77450

Medical Colleagues of Texas / ID # 819, Katy

77573

Maximos OB/GYN / ID # 737, League City

77702

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

78154

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

78503

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

78626

Georgetown OB/GYN / ID # 770, Georgetown

78660

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

78705

Women Partners in Health / ID # 836, Austin

78758

Austin Area ObGyn PLLC / ID # 701, Austin

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

80111

Center for Women's Health / ID # 761, Greenwood Village

80209

Downtown Women's Health Care / ID # 718, Denver

80228

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

83646

Sonara Clinical Research, LLC / ID # 720, Meridian

84020

Physicians Research Options PRO / ID # 766, Draper

84062

Physicians' Res Options - PG / ID # 833, Pleasant Grove

84107

Wasatch Clinical Research / ID # 746, Salt Lake City

84124

Highland Clinical Research / ID # 708, Salt Lake City

85032

Precision Trials AZ, LLC / ID # 783, Phoenix

85209

Mesa Obstetricians and Gyneocologists / ID # 790, Mesa

85712

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

Visions Clinical Research-Tucson / ID # 754, Tucson

87102

Albuquerque Clinical Trials, Inc. / ID # 707, Albuquerque

89113

Office of Edmond Pack, MD / Id # 818, Las Vegas

90057

Matrix Clinical Research / ID # 751, Los Angeles

90255

Join Clinical Trials / ID # 778, Huntington Park

90650

Futura Research, Org / ID # 781, Norwalk

90806

Long Beach Clinical Trials, LLC / ID # 768, Long Beach

91402

National Research Institute / ID # 805, Panorama City

92114

Precision Research Institute / ID # 792, San Diego

92119

MD Strategies Research Centers / ID # 765, San Diego

97239

Oregon Health & Science University / ID # 791, Portland

98105

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

98109

Seattle Reproductive Medicine / ID # 811, Seattle

33196-1554

LCC Medical Research Institute / ID # 814, Miami

32806-1133

Omega Research Orlando, LLC / ID # 785, Orlando

70535-5100

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

02720

NECCR Fall River, LLC / Id # 712, Fall River

08648

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

T4N 6V7

CARe Clinic / ID # 872, Red Deer

L8S 4K1

McMaster University Medical Centre / ID # 870, Hamilton

N8N C52

Victory Reproductive Care / ID # 873, Windsor

00716

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

00717

Puerto Rico Medical Research Inc. / ID # 890, Ponce

All Listed Sponsors
lead

Kissei Pharmaceutical Co., Ltd.

INDUSTRY

NCT03986944 - A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain | Biotech Hunter | Biotech Hunter