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

ClinicalTrials.gov ID: NCT04003155

Public ClinicalTrials.gov record NCT04003155. 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
NCT04003155
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Enrollment
527 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 10, 2019
Primary completion
Oct 28, 2020
Completion
Aug 10, 2021
Last update posted
Nov 3, 2024

2019 – 2021

United States locations

U.S. sites
72
U.S. states
24
U.S. cities
65
Facility City State ZIP Site status
SEC Clinical Research Andalusia Alabama 36420
Central Research Associates Birmingham Alabama 59405
Achieve Clinical Research, LLC Ensley Alabama 35218
Elite Clinical Studies, LLC Phoenix Arizona 85018
Eclipse Clinical Research Tucson Arizona 85745
Advanced Clinical Research - Rancho Paseo Banning California 92220
Hope Clinical Research, LLC Canoga Park California 91303
Alliance Research Inc Canoga Park California 91304
Marvel Clinical Research Huntington Beach California 92647
Grossmont Center for Clinical Research La Mesa California 91942
National Research Institute - Panorama Los Angeles California 90057
Northern California Research Sacramento California 95821
Precision Research Institute, Inc San Diego California 92114
Coastal Connecticut Research, LLC New London Connecticut 06320
Emerson Clinical Research Institute Washington D.C. District of Columbia 20011
Precision Clinical Research Coral Springs Florida 33065
American Research Institute, Inc. Cutler Bay Florida 33157
Avail Clinical Research, LLC DeLand Florida 32720
Universal Axon Clinical Research Doral Florida 33166
Fleming Island Center for Clinical Research Fleming Island Florida 32003
Clinical Physiology Associates Fort Myers Florida 33912
Vital Pharma Research Inc. Hialeah Florida 33016
Health Awareness Jupiter Florida 33458
GYN Research Center Kissimmee Florida 34741
Multi-Specialty Research Associates, Inc. Lake City Florida 32055
Altus Research Lake Worth Florida 33461
Medical Research Center of Miami II Miami Florida 33134
Spotlight research center Miami Florida 33176
New Age Medical Research Corporation Miami Florida 33186
Suncoast Clinical Research, Inc. New Port Richey Florida 34652
Clinical Neuroscience Solutions, Inc Orlando Florida 32801
Clinical Neuroscience Solutions, Inc Orlando Florida 32806
Cornerstone Research Institute Orlando Florida 32822
St. Johns Center for Clinical Research Ponte Vedra Florida 32081
Health Awareness Port Saint Lucie Florida 34952
International Clinical Research Sanford Florida 32771
Premier Medical Associates The Villages Florida 32159
Better Health Greater Life Atlanta Georgia 30312
Gwinnett Research Institute Buford Georgia 30519
IACT Health Columbus Georgia 31904
NuDirections Clinical Research Duluth Georgia 30096
Infinite Clinical Trials Riverdale Georgia 30274
The Healing Sanctuary, LLC Idaho Falls Idaho 83404
Avant Research Associates, LLC Crowley Louisiana 70526
Centex Studies, Inc. Lake Charles Louisiana 70601
Saginaw Valley Medical Research Group, Llc Saginaw Michigan 48604
Montana Medical Research Inc Missoula Montana 59801
Quality Clinical Research, Inc Omaha Nebraska 68114
Excel Clinical Research, LLC Las Vegas Nevada 89109
Office Of Edmond Pack, Md Las Vegas Nevada 89113
Rochester Clinical Research, Inc. Rochester New York 14609
Unified Women's Clinical Research Greensboro North Carolina 27408
Unified Womens Clinical Research Raleigh North Carolina 27607
Wake Research Associates, LLC Raleigh North Carolina 27612
Unified Women's Clinical Research Winston-Salem North Carolina 27103
Lillestol Research, LLC Fargo North Dakota 58104
Velocity Clinical Research Cincinnati Ohio 45242
Complete Healthcare For Women Columbus Ohio 43231
Neuro-Behavioral Clinical Research, Inc North Canton Ohio 44720
Philadelphia Clinical Research, LLC Philadelphia Pennsylvania 19114
Ocean State Clinical Research Partners Lincoln Rhode Island 02865
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464
Coastal Carolina Research Center North Charleston South Carolina 29406
Palmetto Clinical Research Summerville South Carolina 29485
Invocare Clinical Research Center West Columbia South Carolina 29169
Medical Research Center of Memphis LLC Memphis Tennessee 38120
International Clinical Research Murfreesboro Tennessee 37130
Accent Clinical Research Professionals Allen Texas 75013
DiscoveResarch, Inc. Bryan Texas 77802
Protenium Clinical Research, LLC Hurst Texas 76054
EPIC Medical Research Murray Utah 84123
Tidewater Clinical Research, Inc. Virginia Beach Virginia 23456

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 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04003155, 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 3, 2024 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04003155 live on ClinicalTrials.gov.

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