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

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.
NCT04003155

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0301

EudraCT ID

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

2018-003528-35

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 - Aug 2021

Masking

Double (Participant, Investigator)

Enrollment number

527

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

New Age Medical Research Corporation

Miami, United States, 33186

Clinical Neuroscience Solutions, Inc

Orlando, United States, 32806

Lillestol Research, LLC

Fargo, United States, 58104

Unified Women's Clinical Research

Greensboro, United States, 27408

ACRI

Sycamore, United States, 60178

Site ES34002

Madrid, Spain, 28023

Site PL48002

Katowice, Poland, 40-724

Office Of Edmond Pack, Md

Las Vegas, United States, 89113

OnSite Clinical Solutions, LLC

Charlotte, United States, 28277

Gadolin Research, LLC

Beaumont, United States, 77702

Site UA38001

Zaporizhzhya, Ukraine, 69068

Aviva Research

Escondido, United States, 92026

Site CZ42003

Vodnany, Czech Republic, 389 01

Advanced Clinical Research - Rancho Paseo

Banning, United States, 92220

Site GB44003

Orpington, United Kingdom, BR5 3QG

Site CZ42001

Olomouc, Czech Republic, 772 00

The Jackson Clinic

Jackson, United States, 38305

PMG Research of Hickory, LLC

Hickory, United States, 28601

Carolina Insitute for Clinical Research

Fayetteville, United States, 28304

Site GB44004

Middlesex, United Kingdom, HA6 2RN

Radiant Research

Akron, United States, 44311

Site PL48008

Katowice, Poland, 40-018

Montana Medical Research Inc

Missoula, United States, 59801

Coastal Carolina Research Center

Mt. Pleasant, United States, 29464

Rochester Clinical Research, Inc.

Rochester, United States, 14609

Alliance of Multispecialty Research, LLC

Wichita, United States, 67205

Omega Research Consultants

Orlando, United States, 32808

Precision Clinical Research

Coral Springs, United States, 33065

Northeast Clinical Research Centers, Inc.

Schertz, United States, 78154

Invocare Clinical Research Center

West Columbia, United States, 29169

Site CZ42002

Olomouc, Czech Republic, 779 00

Medical Research Center of Miami II

Miami, United States, 33134

Site ES34004

Sevilla, Spain, 41018

Fleming Island Center for Clinical Research

Fleming Island, United States, 32003

NuDirections Clinical Research

Duluth, United States, 30096

American Research Institute, Inc.

Cutler Bay, United States, 33157

Vital Pharma Research Inc.

Hialeah, United States, 33016

Altus Research

Lake Worth, United States, 33461

Eclipse Clinical Research

Tucson, United States, 85745

Womens Health USA, Inc.

Champaign, United States, 61820

Downtown L.A. Research Center, Inc.

Los Angeles, United States, 90017

Arizona Research Center

Phoenix, United States, 85053

Gwinnett Research Institute

Buford, United States, 30519

Site PL48003

Bialystok, Poland, 15-224

Palmetto Clinical Research

Summerville, United States, 29485

Centex Studies, Inc.

Lake Charles, United States, 70601

Excel Clinical Research, LLC

Las Vegas, United States, 89109

Spotlight research center

Miami, United States, 33176

Marvel Clinical Research

Huntington Beach, United States, 92647

Clinical Neuroscience Solutions, Inc

Orlando, United States, 32801

Clinical Research Associates

Nashville, United States, 37203

Site PL48013

Katowice, Poland, 40-301

Site PL48004

Katowice, Poland, 40-611

International Clinical Research

Murfreesboro, United States, 37130

Multi-Specialty Research Associates, Inc.

Lake City, United States, 32055

Northern California Research

Sacramento, United States, 95821

Site PL48005

Poznan, Poland, 60-848

Alliance Research Inc

Canoga Park, United States, 91304

Unified Women's Clinical Research

Winston Salem, United States, 27103

Cornerstone Research Institute

Orlando, United States, 32822

Grossmont Center for Clinical Research

La Mesa, United States, 91942

Site CA15001

Quebec, Canada, G1N 4V3

National Research Institute – Panorama

Los Angeles, United States, 90057

Pearland Physicians

Pearland, United States, 77581

Site GB44001

Wokingham, United Kingdom, RG40 1XS

Site PL48007

Lublin, Poland, 20362

DiscoveResarch, Inc.

Bryan, United States, 77802

GYN Research Center

Kissimmee, United States, 34741

International Clinical Research

Sanford, United States, 32771

Avail Clinical Research, LLC

Deland, United States, 32720

Investigators Research Group, Llc

Brownsburg, United States, 46254

Upstate Clinical Research Associates LLC

Williamsville, United States, 14221

Site CA15003

Brampton, Canada, L6T 0G1

East Valley Family Physicians

Chandler, United States, 85224

Unified Womens Clinical Research

Raleigh, United States, 27607

Velocity Clinical Research

Cincinnati, United States, 45242

Site HU36004

Debrecen, Hungary, 4024

Complete Healthcare For Women

Columbus, United States, 43231

Site PL48012

Katowice, Poland, 40-648

EPIC Medical Research

Murray, United States, 84123

Coastal Carolina Research Center

North Charleston, United States, 29406

Coastal Connecticut Research, LLC

New London, United States, 06320

Tidewater Clinical Research, Inc.

Virginia Beach, United States, 23456

Atlanta Women's Research Institute, Inc.

Atlanta, United States, 30342

Site UA38002

Zaporizhzhya, Ukraine, 69065

Avant Research Associates, LLC

Crowley, United States, 70526

Women's Medical Group of Upland

Upland, United States, 91786

Achieve Clinical Research, LLC

Ensley, United States, 35218

St. Johns Center for Clinical Research

Ponte Vedra, United States, 32081

The Healing Sanctuary, LLC

Idaho Falls, United States, 83404

Protenium Clinical Research, LLC

Hurst, United States, 76054

Ocean State Clinical Research Partners

Lincoln, United States, 02865

Site ES34001

Barcelona, Spain, 08850

Alpha Science Research LLC

Miami, United States, 33186

Sundance Clinical Research, LLC

St Louis, United States, 63141

Aventiv Research, Inc.

Columbus, United States, 43213

Site PL48009

Warszawa, Poland, 02-679

Avant Research Associates, LLC

Austin, United States, 78704

Elite Clinical Studies, LLC

Phoenix, United States, 85018

Site CA15004

Quebec, Canada, G1W 4R4

Hope Clinical Research, LLC

Canoga Park, United States, 91303

Site GB44002

Coventry, United Kingdom, CV3 4FJ

Suncoast Clinical Research, Inc.

New Port Richey, United States, 34652

Health Awareness

Port St. Lucie, United States, 34952

Florida Medical Research

Gainesville, United States, 32607

Bay State Clinical Trials, Inc.

Watertown, United States, 02472

Central Research Associates

Birmingham, United States, 59405

Medical Research Center of Memphis LLC

Memphis, United States, 38120

Multicare Health System Research Institute

Tacoma, United States, 98405

Philadelphia Clinical Research, LLC

Philadelphia, United States, 19114

Medical Research International

Oklahoma City, United States, 73109

Millennium Clinical Trials

Thousand Oaks, United States, 91360

Site PL48001

Warszawa, Poland, 02-798

Quality Clinical Research, Inc

Omaha, United States, 68114

Infinite Clinical Trials

Riverdale, United States, 30274

Accent Clinical Research Professionals

Allen, United States, 75013

Site CA15002

Point Claire, Canada, H9R 4S3

Saginaw Valley Medical Research Group, Llc

Saginaw, United States, 48604

Better Health Greater Life

Atlanta, United States, 30312

Site ES34003

Madrid, Spain, 28009

Clinical Physiology Associates

Fort Myers, United States, 33912

Neuro-Behavioral Clinical Research, Inc

North Canton, United States, 44720

Premier Research Group

Clarksville, United States, 37040

Unified Women's Clinical Research

Morehead, United States, 28557

Site HU36002

Szekesfeherver, Hungary, 8000

Universal Axon Clinical Research

Doral, United States, 33166

WR-Mount Vernon Clinical Research

Chattanooga, United States, 37421

Tekton Research - Georgetown

Austin, United States, 78745

Site CA15006

Quebec City, Canada, G3K 2P8

Medpharmics, LLC

Metairie, United States, 70006

Site CA15005

Newmarket, Canada, L3Y 5G8

Health Awareness

Jupiter, United States, 33458

Site PL48011

Rybnik, Poland, 44-200

IACT Health

Columbus, United States, 31904

Site PL48010

Podlasie, Poland, 15-267

Site PL48014

Swidnik, Poland, 21040

Clinical Trials of Texas

San Antonio, United States, 78229

SEC Clinical Research

Andalusia, United States, 36420

Emerson Clinical Research Institute

Washington, United States, 20011

Wake Research Associates, LLC

Raleigh, United States, 27612

ProHEALTH Care Associates, LLP

Port Jefferson, United States, 11777

Precision Research Institute, Inc

San Diego, United States, 92114

Precision Clinical Research

Sunrise, United States, 33351

Site HU36001

Kecskemet, Hungary, 6000

Charlottesville Medical Research

Charlottesville, United States, 22911

Premier Medical Associates

The Villages, United States, 32159

HD Research Group

Bellaire, United States, 77401

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