Study Details

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A study to find out if fezolinetant helps reduce moderate to severe hot flashes in women going through menopause - 2

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.
NCT04003142

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0302

EudraCT ID

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

2018-003529-27

Follow Trial

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 - Apr 2021

Masking

Double (Participant, Investigator)

Enrollment number

501

A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering from Moderate to Severe 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

Medical Health Center & Research

Miami, United States, 33186

Suncoast Research

Miami, United States, 33176

Site CA15001

Victoriaville, Canada, G6P 6P6

Wasatch Clinical Research, LLC

Salt Lake City, United States, 84107

Centex Studies, Inc.

Houston, United States, 77058

MedPharmics, LLC

Phoenix, United States, 85015

California Center for Clinical Research

Arcadia, United States, 91007

Pharmasite Research Inc

Baltimore, United States, 21210

Alabama Clinical Therapeutics, LLC

Birmingham, United States, 35205

Research Protocol Management Specialists

Pittsburgh, United States, 15243

Meridien Research

St. Petersburg, United States, 33709

Site CA15007

Levis, Canada

Progressive Medical Research

Port Orange, United States, 32127

Sensible Healthcare LLC

Ocoee, United States, 34761

Comprehensive Clinical Development

West Palm Beach, United States, 33409

Wake Research Associates, LLC

San Diego, United States, 92108

Bayview Research Group

Valley Village, United States, 91607

Circuit Clinical

West Seneca, United States, 14224

Praetorian Pharmaceutical Research

Marrero, United States, 70072

Site CZ42005

Tabor 3, Czech Republic, 39003

Site PL48006

Poznan, Poland, 60-192

Clinical Trials of South Carolina

Charleston, United States, 29406

Pioneer Research Solutions, Inc.

Houston, United States, 77099

Site CZ42003

Vsetin, Czech Republic, 75501

Hassman Research Institute, LLC

Berlin, United States, 08009

Precision Trials

Phoenix, United States, 85032

Nature Coast Clinical Research

Crystal River, United States, 34429

Corner Canyon Obstetrics and Gynecology

Draper, United States, 84020

CTI

Cincinnati, United States, 45227

Sunset Point Medical Associates

Palm Harbor, United States, 34684

Alabama Clinical Therapeutics, LLC

Birmingham, United States, 35235

Site LV37103

Riga, Latvia

Physicians' Research Options/Red Rocks OB/GYN

Lakewood, United States, 80228

WR-Mount Vernon Clinical Research

Sandy Springs, United States, 30328

Synexus Clinical Research

Chicago, United States, 60602

Sc Clinical Research

Garden Grove, United States, 92844

Agile Clinical Research Trials, LLC

Atlanta, United States, 30328

Advances in Health

Houston, United States, 77030

Site PL48013

Elblag, Poland, 82-300

Site GB44001

Shipley, United Kingdom, BD18 3SA

Site CA15002

Sherbrooke, Canada, J1L 0H8

Central Phoenix Medical Clinic

Phoenix, United States, 85020

Site CZ42007

Pisek, Czech Republic, 39701

North Spokane Women's Health

Spokane, United States, 99207

Dream Team Clinical Research, LLC

Pomona, United States, 91767

Elite Clinical Trials

Blackfoot, United States, 83221

Site PL48003

Warszawa, Poland, 02777

Bioclinica Research, Melbourne

Melbourne, United States, 32940

Medical Research Centers of South Florida, Inc.

Miami, United States, 33144

Site LV37102

Riga, Latvia, LV-1011

Rosemark Women Care Specialists

Idaho Falls, United States, 83404

Lawrence OBGYN Associates

Lawrenceville, United States, 08648

Arkansas Primary Care Clinic

Little Rock, United States, 72204

iResearch Atlanta LLC

Decatur, United States, 30030

Site CZ42004

Praha 9, Czech Republic, 190 12

Site PL48004

Piaseczno, Poland, 05-500

Medication Management, LLC

Greensboro, United States, 27408

Site ES34004

Sevilla, Spain, 41013

Site PL48011

Krakow, Poland

Clinical Research of Central Florida

Winter Haven, United States, 33880

Site CA15003

Burlington, Canada, L7M 4Y1

Site CA15004

Toronto, Canada, M9W 4L6

Affinity Clinical Research Institute

Oak Brook, United States, 60523

Mesa Obstetricians and Gynecologists

Mesa, United States, 85209

Site PL48010

Warsaw, Poland, 02-201

Dr.R. Garn Mabey, MD,Office Of

Las Vegas, United States, 89128

Advanced Research Institute

New Port Richey, United States, 34653

Excel Clinical Research, LLC

Houston, United States, 77081

Site CZ42002

Plzen, Czech Republic, 31200

Site PL48001

Bydgoszcz, Poland, 85-065

Site PL48009

Katowice, Poland, 40-851

Cypress Medical Research Center

Wichita, United States, 67226

Site CA15008

Quebec, Canada

Rapid Medical Research, Inc.

Cleveland, United States, 44122

Site LV37101

Riga, Latvia, 1005

Site PL48005

Szczecin, Poland, 71-434

Carolina women's research and wellness center

Durham, United States, 27713-2490

Health Research of Hampton Roads Inc

Newport News, United States, 23606

Riverside Clinical Research

Edgewater, United States, 32132

Site GB44004

Corby, United Kingdom, NN17 2UR

Frontier Clinical Research

Smithfield, United States, 15478

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, United States, 32174

Site CZ42006

Praha 2, Czech Republic, 12000

Site HU36002

Budapest, Hungary, 1135

Clinical Neuroscience Solutions, Inc

Memphis, United States, 38119

Site ES34002

Centelles, Spain, 08540

Visions Clinical Research - Tuscon

Tucson, United States, 85712

Physician Care Clinical Research, LLC

Sarasota, United States, 34239-3132

The Center For Pharmaceutical Research

Kansas City, United States, 64114

Horizons Clincial Research Center LLC

Denver, United States, 80220

Florida International Research Center

Miami, United States, 33174

Dr. Marvin Kalafer MD, Office Of

Jenkintown, United States, 19046

Site PL48002

Lublin, Poland, 20-069

Excell Research

Oceanside, United States, 92056

RNA AMERICA,LLC

Sugar Hill, United States, 30518

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

Salt Lake City, United States, 84107

Torrance Clinical Research Institute,Inc

Lomita, United States, 90717

LCC Medical Research Institute, LLC

Miami, United States, 33126

Healthcare Clinical Data Inc

North Miami, United States, 33161

Southern Clinical Research Associates

Metairie, United States, 70001

Radiant Research

Pinellas Park, United States, 33781

Del Sol Research Management

Tucson, United States, 85712

Albuquerque Clinical Trials, Inc.

Albuquerque, United States, 87102

Chattanooga GYN-Oncology

Chattanooga, United States, 37404

Suncoast Clinical Research, Inc.

Miami, United States, 33135

FMC Science

Lampasas, United States, 76550

Site CA15006

Sarnia, Canada, N7T 4X3

Women Under Study, LLC

New Orleans, United States, 70125

Maryland Physicians Edge, P.C. dba Obstetrics and Gynecology

Silver Spring, United States, 20910

Georgia Research for Women

Atlanta, United States, 30312-1220

Site PL48012

Lublin, Poland

ASR, LLC-Advanced Specialty Research

Nampa, United States, 83687

The Clinical Research Center, LLC

Carrollton, United States, 75007

Site HU36001

Debrecen, Hungary, 4012

GCP Clinical Research, LLC

Tampa, United States, 33614

Clinical Trials Research

Sacramento, United States, 95821

Olympian Clinical Research

Clearwater, United States, 33757

Bosque Women's Care

Albuquerque, United States, 87109-4640

Avant Research Associates, LLC

Huntsville, United States, 35803

Granger Medical Clinic

Riverton, United States, 84065

Bioclinica Research

Orlando, United States, 32806

Helix Biomedics

Boynton Beach, United States, 33436

Greater Cincinnati Ob/Gyn, Inc.

Cincinnati, United States, 45219-2906

Renaissance Research and Medical Group, Inc.

Cape Coral, United States, 33991

Synexs Clinical Research US, Inc.

Murray, United States, 84123

Site CA15009

Toronto, Canada, M3J 2C5

Site ES34001

Madrid, Spain, 28041

Site ES34003

Aravaca, Spain, 28023

OB/GYN Associates of Erie

Erie, United States, 16507

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98115

QPS MRA, LLC

Miami, United States, 33143

Site PL48008

Lodz, Poland, 91-053

Site GB44002

Romford, United Kingdom, RM1 3PJ

Downtown Women's Health Care

Denver, United States, 80209

Site PL48014

Lodz, Poland, 90-602

Women's Healthcare Affiliates

San Diego, United States, 92111

Hwc Women's Research Center

Englewood, United States, 45322

Georgia Clinical Research

Snellville, United States, 30078

Sante Comprehensive Women's Healthcare

Johnson City, United States, 13790

ClinRx Research

Plano, United States, 75024

Premier Gynecology & Wellness

Charlotte, United States, 28207

MediSphere Medical Research

Evansville, United States, 47714

CITrials, Inc.

Santa Ana, United States, 92705

Clinical Research Center of Nevada (CRCN)

Las Vegas, United States, 89104-3218

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