Study Details

A study to find out how safe long-term treatment with fezolinetant is in women with hot flashes going through menopause

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04003389

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0304

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2019-000275-16

Condition

Hot Flashes

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

40 years - 65 years

Sex

Female

Product

fezolinetant

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2019 - Jan 2022

Masking

Double (Participant, Investigator)

Enrollment number

1831

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated with Menopause

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Olympian Clinical Research

Clearwater, United States, 33757

Corner Canyon Obstetrics and Gynecology

Draper, United States, 84020

Women's Medical Group of Upland

Upland, United States, 91786

Medication Management, LLC

Greensboro, United States, 27408

Rosemark Women Care Specialists

Idaho Falls, United States, 83404

Site CA15004

Point Claire, Canada, H9R 4S3

Physician Care Clinical Research, LLC

Sarasota, United States, 34239-3132

Bosque Women's Care

Albuquerque, United States, 87109-4640

Site CA15003

Sherbrooke, Canada, J1L 0H8

Horizons Clincial Research Center LLC

Denver, United States, 80220

Site PL48003

Warszawa, Poland, 02-798

Medical Research Center of Miami II

Miami, United States, 33134

Unified Women's Clinical Research

Winston Salem, United States, 27103

Medpharmics, LLC

Metairie, United States, 70006

Alliance Research Inc

Canoga Park, United States, 91304

Advances in Health

Houston, United States, 77030

Mesa Obstetricians and Gynecologists

Mesa, United States, 85209

Infinite Clinical Trials

Riverdale, United States, 30274

Aventiv Research, Inc.

Columbus, United States, 43213

Site UA38002

Kiev, Ukraine, 04050

Clinical Research Advantage, Inc.

Chandler, United States, 85224

ClinRx Research

Plano, United States, 75024

RNA AMERICA,LLC

Sugar Hill, United States, 30518

Clinical Neuroscience Solutions, Inc

Orlando, United States, 32806

Carolina Insitute for Clinical Research

Fayetteville, United States, 28304

Site CA15010

Sarnia, Canada, N7T 4X3

Excel Clinical Research, LLC

Las Vegas, United States, 89109

Granger Medical Clinic

Riverton, United States, 84065

Precision Trials

Phoenix, United States, 85032

Tekton Research - Georgetown

Austin, United States, 78745

MedPharmics, LLC

Gulfport, United States, 35903

MediSphere Medical Research

Evansville, United States, 47714

Chattanooga GYN-Oncology

Chattanooga, United States, 37404

Dr.R. Garn Mabey, MD,Office Of

Las Vegas, United States, 89128

Site PL48012

Katowice, Poland, 40-018

Radiant Research

Pinellas Park, United States, 33781

Site GB44007

Romford, United Kingdom

Healthcare Clinical Data Inc

North Miami, United States, 33161

ProHEALTH Care Associates, LLP

Port Jefferson, United States, 11777

Investigators Research Group, Llc

Brownsburg, United States, 46254

Sunset Point Medical Associates

Palm Harbor, United States, 34684

Charlottesville Medical Research

Charlottesville, United States, 22911

Downtown Women's Health Care

Denver, United States, 80209

Premier Medical Associates

The Villages, United States, 32159

LCC Medical Research Institute, LLC

Miami, United States, 33126

Site PL48002

Katowice, Poland, 40-611

Site ES34005

Centelles, Spain, 08540

California Center for Clinical Research

Arcadia, United States, 91007

Site PL48006

Lublin, Poland, 20-069

Site ES34004

Aravaca, Spain, 28023

Grossmont Center for Clinical Research

La Mesa, United States, 91942

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, United States, 32174

Site GB44006

Middlesex, United Kingdom, HA6 2RN

Georgia Research for Women

Atlanta, United States, 30312-1220

Site CA15005

Brampton, Canada, L6T 0G1

Health Research of Hampton Roads Inc

Newport News, United States, 23606

Palmetto Clinical Research

Summerville, United States, 29485

Progressive Medical Research

Port Orange, United States, 32127

Health Awareness

Port St. Lucie, United States, 34952

Site ES34001

Barcelona, Spain, 08850

WR-Mount Vernon Clinical Research

Sandy Springs, United States, 30328

NuDirections Clinical Research

Duluth, United States, 30096

Premier Research Group

Clarksville, United States, 37040

Achieve Clinical Research, LLC

Ensley, United States, 35218

Coastal Connecticut Research, LLC

New London, United States, 06320

Avant Research Associates, LLC

Huntsville, United States, 35803

Medpharmics LLC

Phoenix, United States, 85015

Sante Comprehensive Women's Healthcare

Johnson City, United States, 13790

Clinical Neuroscience Solutions, Inc

Memphis, United States, 38119

Medical Research Center of Memphis, LLC

Memphis, United States, 38120

Central Research Associates

Birmingham, United States, 59405

Site PL48001

Katowice, Poland, 40-724

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98115

Bayview Research Group

Valley Village, United States, 91607

Unified Women’s Clinical Research

Raleigh, United States, 27607

Clinical Trials of Texas

San Antonio, United States, 78229

Office Of Edmond Pack, Md

Las Vegas, United States, 89113

Advanced Clinical Research-Old Farm OB/GYN (Utah)

Salt Lake City, United States, 84107

Site PL48020

Warsaw, Poland, 02-201

Complete Healthcare For Women

Columbus, United States, 43231

Alliance of Multispecialty Research, LLC

Wichita, United States, 67205

PMG Research of Hickory, LLC

Hickory, United States, 28601

Unified Women's Clinical Research

Morehead, United States, 28557

Atlanta Women's Research Institute, Inc.

Atlanta, United States, 30342

The Center For Pharmaceutical Research

Kansas City, United States, 64114

Southern Clinical Research Associates

Metairie, United States, 70001

Site PL48017

Rybnik, Poland, 44-200

Georgia Clinical Research

Snellville, United States, 30078

North Spokane Women's Health

Spokane, United States, 99207

Emerson Clinical Research institute

Washington, United States, 20011

Florida Medical Research

Gainesville, United States, 32607

Wake Research Associates, LLC

San Diego, United States, 92108

Millennium Clinical Trials

Thousand Oaks, United States, 91360

Precision Clinical Research

Coral Springs, United States, 33065

FMC Science

Lampasas, United States, 76550

Women's Healthcare Affiliates

San Diego, United States, 92111

Pharmasite Research Inc

Baltimore, United States, 21208

National Research Institute – Panorama

Los Angeles, United States, 90057

Upstate Clinical Research Associates LLC

Williamsville, United States, 14221

Agile Clinical Research Trials, LLC

Atlanta, United States, 30328

Site PL48019

Katowice, Poland, 40-851

Hassman Research Institute, LLC

Berlin, United States, 08009

Sc Clinical Research

Garden Grove, United States, 92844

The Jackson Clinic

Jackson, United States, 38305

Multi-Specialty Research Associates, Inc.

Lake City, United States, 32055

Clinical Research Center of Nevada (CRCN)

Las Vegas, United States, 89104-3218

Alpha Science Research LLC

Miami, United States, 33186

Marvel Clinical Research

Huntington Beach, United States, 92647

Multicare Health System Research Institute

Tacoma, United States, 98405

Sundance Clinical Research, LLC

St Louis, United States, 63141

Clinical Research of Central Florida

Winter Haven, United States, 33880

Site PL48016

Poznan, Poland, 60-192

Site CZ42007

Vsetin, Czech Republic, 75501

Site PL48010

Szczecin, Poland, 71-434

Site CZ42004

Praha 9, Czech Republic, 190 12

ClinRx Research

Carrollton, United States, 57007

Site CZ42010

Pisek, Czech Republic, 39701

Site ES34003

Madrid, Spain, 28009

Synexus Clinical Research

Chicago, United States, 60602

Premier Gynecology & Wellness

Charlotte, United States, 28207

Site UA38005

Lviv, Ukraine, 79010

Saginaw Valley Medical Research Group, Llc

Saginaw, United States, 48604

Site PL48005

Bydgoszcz, Poland, 85-065

Gadolin Research, LLC

Beaumont, United States, 77702

CITrials, Inc

Santa Ana, United States, 92705

Clinical Trials of South Carolina

Charleston, United States, 29406

Med Research Of Florida, LLC

Miami, United States, 33186

Vital Pharma Research Inc.

Hialeah, United States, 33016

Site CA15007

Toronto, Canada, M9W 4L6

Precision Clinical Research

Sunrise, United States, 33351

Circuit Clinical

West Seneca, United States, 14224

Site LV37103

Riga, Latvia, LV-1011

Site CZ42009

Praha 2, Czech Republic, 12000

Northern California Research

Sacramento, United States, 95821

CTI

Cincinnati, United States, 45227

Site GB44005

Corby, United Kingdom, NN17 2UR

Affinity Clinical Research Institute

Oak Brook, United States, 60523

Medical Research Centers of South Florida, Inc.

Miami, United States, 33144

EPIC Medical Research

Murray, United States, 84123

Wake Research Associates, LLC

Raleigh, United States, 27612

Lillestol Research, LLC

Fargo, United States, 58104

Del Sol Research Management

Tucson, United States, 85712

Bay State Clinical Trials, Inc.

Watertown, United States, 02472

Tidewater Clinical Research, Inc.

Virginia Beach, United States, 23456

Downtown L.A. Research Center, Inc.

Los Angeles, United States, 90017

Lawrence OBGYN Associates

Lawrenceville, United States, 08648

Universal Axon Clinical Research

Doral, United States, 33166

Visions Clinical Research - Tuscon

Tucson, United States, 85712

Alabama Clinical Therapeutics, LLC

Birmingham, United States, 35235

Central Phoenix Medical Clinic

Phoenix, United States, 85020

Site ES34002

Madrid, Spain, 28041

Physicians' Research Options/Red Rocks OB/GYN

Lakewood, United States, 80228

Wasatch Clinical Research, LLC

Salt Lake City, United States, 84107

Montana Medical Research Inc

Missoula, United States, 59801

Frontier Clinical Research

Smithfield, United States, 15478

Precision Trials

San Diego, United States, 92114

Aviva Research

Escondido, United States, 92026

Altus Research

Lake Worth, United States, 33461

Riverside Clinical Research

Edgewater, United States, 32132

Fleming Island Center for Clinical Research

Fleming Island, United States, 32003

Coastal Carolina Research Center

Mt. Pleasant, United States, 29464

Avail Clinical Research, LLC

Deland, United States, 32720

Rochester Clinical Research, Inc.

Rochester, United States, 14609

New Age Medical Research Corporation

Miami, United States, 33186

Avant Research Associates, LLC

Crowley, United States, 70526

GCP Clinical Research, LLC

Tampa, United States, 33614

Greater Cincinnati OB/GYN

Cincinnati, United States, 45267

Site UA38006

Kiev, Ukraine

The Healing Sanctuary, LLC

Idaho Falls, United States, 83404

Site GB44003

Wokingham, United Kingdom, RG40 1XS

Elite Clinical Research, LLC

Phoenix, United States, 85018

Site CZ42008

Vodnany, Czech Republic, 389 01

Cornerstone Research Institute

Orlando, United States, 32822

Womens Health USA, Inc.

Champaign, United States, 61820

Site CZ42006

Plzen, Czech Republic, 31200

Synexs Clinical Research US, Inc.

Murray, United States, 84123

Site UA38001

Zaporizhzhya, Ukraine, 69068

Sensible Healthcare LLC

Ocoee, United States, 34761

Site CZ42003

Olomouc, Czech Republic, 779 00

Site GB44001

Shipley, United Kingdom, BD18 3SA

Site ES34007

Sevilla, Spain, 41013

Radiant Research

Akron, United States, 44311

Excell Research

Oceanside, United States, 92056

Clinical Physiology Associates

Fort Myers, United States, 33912

Quality Clinical Research, Inc

Omaha, United States, 68114

Centex Studies, Inc.

Houston, United States, 77058

Site UA38004

Zaporizhzhya, Ukraine, 69065

Arkansas Primary Care Clinic

Little Rock, United States, 72204

Cypress Medical Research Center

Wichita, United States, 67226

DiscoveResarch, Inc.

Bryan, United States, 77802

Protenium Clinical Research, LLC

Hurst, United States, 76054

Site PL48018

Lodz, Poland, 91-053

International Clinical Research

Murfreesboro, United States, 37130

Site CA15012

Levis, Canada

Unified Women's Clinical Research

Greensboro, United States, 27408

Northeast Clinical Research Centers, Inc.

Schertz, United States, 78154

Site PL48004

Bialystok, Poland, 15-224

Site PL48013

Warszawa, Poland, 02-679

Empire Clinical Research

Pomona, United States, 91767

Site CA15006

Burlington, Canada, L7M 4Y1

Philadelphia Clinical Research, LLC

Philadelphia, United States, 19114

Pioneer Research Solutions, Inc.

Houston, United States, 77099

Suncoast Clinical Research, Inc.

New Port Richey, United States, 34652

Accent Clinical Research Professionals

Allen, United States, 75013

Site GB44002

Yaxley, United Kingdom, PE7 3JL

Site PL48014

Lublin, Poland, 20362

The Clinical Trial Center LLC

Jenkintown, United States, 19046

Florida International Research Center

Miami, United States, 33174

Site PL48007

Warszawa, Poland, 02777

Site PL48015

Podlasie, Poland, 15-267

St. Johns Center for Clinical Research

Ponte Vedra, United States, 32081

Site CA15009

Quebec, Canada, G1W 4R4

Albuquerque Clinical Trials, Inc.

Albuquerque, United States, 87102

Omega Research Consultants

Orlando, United States, 32808

Alabama Clinical Therapeutics, LLC

Birmingham, United States, 35205

Site GB44004

Kenilworth, United Kingdom, CV8 1JD

Site LV37102

Riga, Latvia, 1005

SEC Clinical Research

Andalusia, United States, 36420

Bioclinica Research

Orlando, United States, 32806

Neuro-Behavioral Clinical Research, Inc

North Canton, United States, 44720

Excel Clinical Research, LLC

Sugarland, United States, 77478

Hwc Women's Research Center

Englewood, United States, 45322

Health Awareness

Jupiter, United States, 33458

Site LV37101

Riga, Latvia, 1010

Site CA15002

Quebec, Canada, G1N 4V3

WR Clinsearch, LLC

Chattanooga, United States, 37421

Carolina women's research and wellness center

Durham, United States, 27714

Site GB44008

Sidcup, United Kingdom, DA146LT

Hope Research Institute

Canoga Park, United States, 91303

OnSite Clinical Solutions, LLC

Charlotte, United States, 28277

Site CA15001

Victoriaville, Canada, G6P 6P6

Site CZ42005

Tabor 3, Czech Republic, 39003

Spotlight research center

Miami, United States, 33176

Site CA15011

Newmarket, Canada, L3Y 5G8

Nature Coast Clinical Research

Crystal River, United States, 34429

Advanced Research Institute

New Port Richey, United States, 34653

OB-GYN Associates

Erie, United States, 16507

Eclipse Clinical Research

Tucson, United States, 85745

Clinical Trials Research

Sacramento, United States, 95821

Site CZ42001

Olomouc, Czech Republic, 772 00

Site PL48008

Poznan, Poland, 60-848

iResearch Atlanta LLC

Decatur, United States, 30030

Praetorian Pharmaceutical Research

Marrero, United States, 70072