ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2

ClinicalTrials.gov ID: NCT04003142

Public ClinicalTrials.gov record NCT04003142. 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 May 20, 2026, 8:09 AM 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, 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 identification

NCT ID
NCT04003142
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Enrollment
501 participants

Conditions and interventions

Conditions

Interventions

  • Fezolinetant Drug
  • placebo Drug

Drug

Eligibility (public fields only)

Age range
40 Years to 65 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
Jul 9, 2019
Primary completion
Jul 29, 2020
Completion
Apr 22, 2021
Last update posted
Nov 4, 2024

2019 – 2021

United States locations

U.S. sites
65
U.S. states
21
U.S. cities
56
Facility City State ZIP Site status
Mesa Obstetricians and Gynecologists Mesa Arizona 85209
Precision Trials Phoenix Arizona 85032
Visions Clinical Research - Tuscon Tucson Arizona 85712
Excell Research Oceanside California 92056
Dream Team Clinical Research, LLC Pomona California 91767
Clinical Trials Research Sacramento California 95821
Wake Research Associates, LLC San Diego California 92108
Women's Healthcare Affiliates San Diego California 92111
Bayview Research Group Valley Village California 91607
Downtown Women's Health Care Denver Colorado 80209
Horizons Clincial Research Center LLC Denver Colorado 80220
Physicians' Research Options/Red Rocks OB/GYN Lakewood Colorado 80228
Helix Biomedics Boynton Beach Florida 33436
Renaissance Research and Medical Group, Inc. Cape Coral Florida 33991
Nature Coast Clinical Research Crystal River Florida 34429
Bioclinica Research, Melbourne Melbourne Florida 32940
LCC Medical Research Institute, LLC Miami Florida 33126
Suncoast Clinical Research, Inc. Miami Florida 33135
Suncoast Research Miami Florida 33176
Medical Health Center & Research Miami Florida 33186
Healthcare Clinical Data Inc North Miami Florida 33161
Sensible Healthcare LLC Ocoee Florida 34761
Bioclinica Research Orlando Florida 32806
Ormond Medical Arts Pharmaceutical Research Center Ormond Beach Florida 32174
Progressive Medical Research Port Orange Florida 32127
Physician Care Clinical Research, LLC Sarasota Florida 34239-3132
Meridien Research St. Petersburg Florida 33709
GCP Clinical Research, LLC Tampa Florida 33614
Comprehensive Clinical Development West Palm Beach Florida 33409
Clinical Research of Central Florida Winter Haven Florida 33880
Georgia Research for Women Atlanta Georgia 30312-1220
Agile Clinical Research Trials, LLC Atlanta Georgia 30328
iResearch Atlanta LLC Decatur Georgia 30030
WR-Mount Vernon Clinical Research Sandy Springs Georgia 30328
Georgia Clinical Research Snellville Georgia 30078
Elite Clinical Trials Blackfoot Idaho 83221
ASR, LLC-Advanced Specialty Research Nampa Idaho 83687
Affinity Clinical Research Institute Oak Brook Illinois 60523
Cypress Medical Research Center Wichita Kansas 67226
Praetorian Pharmaceutical Research Marrero Louisiana 70072
Southern Clinical Research Associates Metairie Louisiana 70001
Women Under Study, LLC New Orleans Louisiana 70125
Pharmasite Research Inc Baltimore Maryland 21210
Clinical Research Center of Nevada (CRCN) Las Vegas Nevada 89104-3218
Dr.R. Garn Mabey, MD,Office Of Las Vegas Nevada 89128
Hassman Research Institute, LLC Berlin New Jersey 08009
Albuquerque Clinical Trials, Inc. Albuquerque New Mexico 87102
Bosque Women's Care Albuquerque New Mexico 87109-4640
Circuit Clinical West Seneca New York 14224
Premier Gynecology & Wellness Charlotte North Carolina 28207
Medication Management, LLC Greensboro North Carolina 27408
Hwc Women's Research Center Englewood Ohio 45322
OB/GYN Associates of Erie Erie Pennsylvania 16507
Dr. Marvin Kalafer MD, Office Of Jenkintown Pennsylvania 19046
Research Protocol Management Specialists Pittsburgh Pennsylvania 15243
Clinical Neuroscience Solutions, Inc Memphis Tennessee 38119
The Clinical Research Center, LLC Carrollton Texas 75007
Advances in Health Houston Texas 77030
Centex Studies, Inc. Houston Texas 77058
FMC Science Lampasas Texas 76550
ClinRx Research Plano Texas 75024
Granger Medical Clinic Riverton Utah 84065
Wasatch Clinical Research, LLC Salt Lake City Utah 84107
Seattle Women's: Health, Research, Gynecology Seattle Washington 98115
North Spokane Women's Health Spokane Washington 99207

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 28 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04003142, 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 Nov 4, 2024 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04003142 live on ClinicalTrials.gov.

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