ClinicalTrials.gov record
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
ClinicalTrials.gov ID: NCT04003389
Public ClinicalTrials.gov record NCT04003389. 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 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 identification
- NCT ID
- NCT04003389
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 1,831 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
- Jan 3, 2022
- Completion
- Jan 3, 2022
- Last update posted
- Nov 4, 2024
2019 – 2022
United States locations
- U.S. sites
- 142
- U.S. states
- 32
- U.S. cities
- 111
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEC Clinical Research | Andalusia | Alabama | 36420 | — |
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35205 | — |
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Achieve Clinical Research, LLC | Ensley | Alabama | 35218 | — |
| Mesa Obstetricians and Gynecologists | Mesa | Arizona | 85209 | — |
| Medpharmics LLC | Phoenix | Arizona | 85015 | — |
| Precision Trials | Phoenix | Arizona | 85032 | — |
| Del Sol Research Management | Tucson | Arizona | 85712 | — |
| Visions Clinical Research - Tuscon | Tucson | Arizona | 85712 | — |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | — |
| Hope Research Institute | 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 | — |
| Downtown L.A. Research Center, Inc. | Los Angeles | California | 90017 | — |
| National Research Institute - Panorama | Los Angeles | California | 90057 | — |
| Excell Research | Oceanside | California | 92056 | — |
| Clinical Trials Research | Sacramento | California | 95821 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Wake Research Associates, LLC | San Diego | California | 92108 | — |
| Women's Healthcare Affiliates | San Diego | California | 92111 | — |
| CITrials, Inc | Santa Ana | California | 92705 | — |
| Millennium Clinical Trials | Thousand Oaks | California | 91360 | — |
| Women's Medical Group of Upland | Upland | California | 91786 | — |
| Bayview Research Group | Valley Village | California | 91607 | — |
| Downtown Women's Health Care | Denver | Colorado | 80209 | — |
| Horizons Clincial Research Center LLC | Denver | Colorado | 80220 | — |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | — |
| Emerson Clinical Research institute | Washington D.C. | District of Columbia | 20011 | — |
| Olympian Clinical Research | Clearwater | Florida | 33757 | — |
| Precision Clinical Research | Coral Springs | Florida | 33065 | — |
| Nature Coast Clinical Research | Crystal River | Florida | 34429 | — |
| 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 | — |
| Florida Medical Research | Gainesville | Florida | 32607 | — |
| Vital Pharma Research Inc. | Hialeah | Florida | 33016 | — |
| Health Awareness | Jupiter | Florida | 33458 | — |
| Multi-Specialty Research Associates, Inc. | Lake City | Florida | 32055 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| LCC Medical Research Institute, LLC | Miami | Florida | 33126 | — |
| Medical Research Center of Miami II | Miami | Florida | 33134 | — |
| Medical Research Centers of South Florida, Inc. | Miami | Florida | 33144 | — |
| Florida International Research Center | Miami | Florida | 33174 | — |
| Spotlight research center | Miami | Florida | 33176 | — |
| Med Research Of Florida, LLC | Miami | Florida | 33186 | — |
| New Age Medical Research Corporation | Miami | Florida | 33186 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Healthcare Clinical Data Inc | North Miami | Florida | 33161 | — |
| Sensible Healthcare LLC | Ocoee | Florida | 34761 | — |
| Bioclinica Research | Orlando | Florida | 32806 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32806 | — |
| Omega Research Consultants | Orlando | Florida | 32808 | — |
| Cornerstone Research Institute | Orlando | Florida | 32822 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Sunset Point Medical Associates | Palm Harbor | Florida | 34684 | — |
| Radiant Research | Pinellas Park | Florida | 33781 | — |
| St. Johns Center for Clinical Research | Ponte Vedra | Florida | 32081 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Health Awareness | Port Saint Lucie | Florida | 34952 | — |
| Precision Clinical Research | Sunrise | Florida | 33351 | — |
| GCP Clinical Research, LLC | Tampa | Florida | 33614 | — |
| Premier Medical Associates | The Villages | Florida | 32159 | — |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | — |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | 30328 | — |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | — |
| NuDirections Clinical Research | Duluth | Georgia | 30096 | — |
| Infinite Clinical Trials | Riverdale | Georgia | 30274 | — |
| WR-Mount Vernon Clinical Research | Sandy Springs | Georgia | 30328 | — |
| Georgia Clinical Research | Snellville | Georgia | 30078 | — |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | — |
| The Healing Sanctuary, LLC | Idaho Falls | Idaho | 83404 | — |
| Womens Health USA, Inc. | Champaign | Illinois | 61820 | — |
| Affinity Clinical Research Institute | Oak Brook | Illinois | 60523 | — |
| Investigators Research Group, Llc | Brownsburg | Indiana | 46254 | — |
| MediSphere Medical Research | Evansville | Indiana | 47714 | — |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | — |
| Avant Research Associates, LLC | Crowley | Louisiana | 70526 | — |
| Praetorian Pharmaceutical Research | Marrero | Louisiana | 70072 | — |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | — |
| Medpharmics, LLC | Metairie | Louisiana | 70006 | — |
| Pharmasite Research Inc | Baltimore | Maryland | 21208 | — |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | — |
| Saginaw Valley Medical Research Group, Llc | Saginaw | Michigan | 48604 | — |
| Montana Medical Research Inc | Missoula | Montana | 59801 | — |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | — |
| Clinical Research Center of Nevada (CRCN) | Las Vegas | Nevada | 89104-3218 | — |
| Excel Clinical Research, LLC | Las Vegas | Nevada | 89109 | — |
| Office Of Edmond Pack, Md | Las Vegas | Nevada | 89113 | — |
| Dr.R. Garn Mabey, MD,Office Of | Las Vegas | Nevada | 89128 | — |
| Hassman Research Institute, LLC | Berlin | New Jersey | 08009 | — |
| Lawrence OBGYN Associates | Lawrenceville | New Jersey | 08648 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Bosque Women's Care | Albuquerque | New Mexico | 87109-4640 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| Circuit Clinical | West Seneca | New York | 14224 | — |
| Upstate Clinical Research Associates LLC | Williamsville | New York | 14221 | — |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28277 | — |
| Carolina women's research and wellness center | Durham | North Carolina | 27714 | — |
| Carolina Insitute for Clinical Research | Fayetteville | North Carolina | 28304 | — |
| Unified Women's Clinical Research | Greensboro | North Carolina | 27408 | — |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28601 | — |
| Unified Women's 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 | — |
| CTI | Cincinnati | Ohio | 45227 | — |
| Greater Cincinnati OB/GYN | Cincinnati | Ohio | 45267 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | — |
| Complete Healthcare For Women | Columbus | Ohio | 43231 | — |
| Hwc Women's Research Center | Englewood | Ohio | 45322 | — |
| Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | 44720 | — |
| OB-GYN Associates | Erie | Pennsylvania | 16507 | — |
| The Clinical Trial Center LLC | Jenkintown | Pennsylvania | 19046 | — |
| Philadelphia Clinical Research, LLC | Philadelphia | Pennsylvania | 19114 | — |
| Frontier Clinical Research | Smithfield | Pennsylvania | 15478 | — |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Chattanooga GYN-Oncology | Chattanooga | Tennessee | 37404 | — |
| WR Clinsearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | — |
| Medical Research Center of Memphis, LLC | Memphis | Tennessee | 38120 | — |
| International Clinical Research | Murfreesboro | Tennessee | 37130 | — |
| Tekton Research - Georgetown | Austin | Texas | 78745 | — |
| Gadolin Research, LLC | Beaumont | Texas | 77702 | — |
| DiscoveResarch, Inc. | Bryan | Texas | 77802 | — |
| Advances in Health | Houston | Texas | 77030 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
| Protenium Clinical Research, LLC | Hurst | Texas | 76054 | — |
| FMC Science | Lampasas | Texas | 76550 | — |
| ClinRx Research | Plano | Texas | 75024 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Northeast Clinical Research Centers, Inc. | Schertz | Texas | 78154 | — |
| Excel Clinical Research, LLC | Sugar Land | Texas | 77478 | — |
| EPIC Medical Research | Murray | Utah | 84123 | — |
| Advanced Clinical Research-Old Farm OB/GYN (Utah) | Salt Lake City | Utah | 84107 | — |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | — |
| Health Research of Hampton Roads Inc | Newport News | Virginia | 23606 | — |
| Tidewater Clinical Research, Inc. | Virginia Beach | Virginia | 23456 | — |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98115 | — |
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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04003389, 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
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04003389 live on ClinicalTrials.gov.