A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
NCT ID: NCT04003389
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1831 participants
INTERVENTIONAL
2019-07-10
2022-01-04
Brief Summary
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The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). To do that, the study looked at the number and severity of the "adverse events." Those were the side effects that study participants had while they were in the study.
The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo was a dummy treatment that looked like medicine but did not have any medicine in it.) Women in this study were picked for 1 of the 3 study treatments by chance alone. The study participants took study treatment for 52 weeks.
This study was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo).
At weeks 2 and 4 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine were collected for laboratory tests. At some study visits, study participants completed questionnaires that were about their quality of life. At the first and last study visits, they had a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA created pictures of the inside of these areas with low-dose x-rays. (The dose was approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still had their uterus had 2 more tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test was transvaginal ultrasound. It used sound waves to create pictures of the organs in the pelvis. The sound waves were transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have had a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not had this test done in the last 12 months had it done at the first study visit. They had done at the last study visit if they were due for their screening mammogram and their own doctor agreed.
The last check-up at the hospital or clinic was at 3 weeks after the last dose of study treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fezolinetant 30 mg
Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, once daily (QD) for a period of 52 Weeks.
fezolinetant
administered orally
Fezolinetant 45 mg
Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD for a period of 52 Weeks.
fezolinetant
administered orally
Placebo
Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, QD for a of period of 52 Weeks.
placebo
administered orally
Interventions
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fezolinetant
administered orally
placebo
administered orally
Eligibility Criteria
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Inclusion Criteria
* Subject must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:
* Spontaneous amenorrhea for ≥ 12 consecutive months
* Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle stimulating hormone \> 40 IU/L), or
* Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
* Subject is seeking treatment for relief for VMS associated with menopause.
* Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters; pulse rate and/or blood pressure; and ECG within the reference range for the population studied, or showing no clinically relevant deviations.
* Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
* Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit.
* Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, and any time during the study in the case of uterine bleeding. The endometrial biopsy obtained at screening must be considered evaluable.
* Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.
* Subject has a negative urine pregnancy test at screening.
* Subject has a negative serology panel (i.e., negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
* Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion Criteria
* Subject has a known substance abuse or alcohol addiction within 6 months of screening.
* Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
* Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.
* Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
* Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
* Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
* Subject has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
* Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant findings at screening.
* Subject has a history within the last 6 months of undiagnosed uterine bleeding.
* Subject has a history of seizures or other convulsive disorders.
* Subject has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
* Subject has active liver disease, jaundice or elevated liver aminotransferases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]), elevated total or direct bilirubin, elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.
* Subject has creatinine \> 1.5 x ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m\^2 at the screening visit.
* Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or who is at significant risk to commit suicide, as assessed at screening and at the time of visit 2 (randomization).
* Subject has previously been enrolled in a clinical trial with fezolinetant.
* Subject is participating concurrently in another interventional study or participated in an interventional study within 28 days prior to screening, or received any investigational drug within 28 days or within 5 half-lives prior to screening, whichever is longer.
* Subject is unable or unwilling to complete the study procedures.
* Subject has any condition which makes the subject unsuitable for study participation.
* Subject has had a partial or full hysterectomy.
40 Years
65 Years
FEMALE
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Executive Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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SEC Clinical Research
Andalusia, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Ensley, Alabama, United States
Mesa Obstetricians and Gynecologists
Mesa, Arizona, United States
Medpharmics LLC
Phoenix, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Del Sol Research Management
Tucson, Arizona, United States
Visions Clinical Research - Tuscon
Tucson, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Hope Research Institute
Canoga Park, California, United States
Alliance Research Inc
Canoga Park, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Grossmont Center for Clinical Research
La Mesa, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
National Research Institute - Panorama
Los Angeles, California, United States
Excell Research
Oceanside, California, United States
Clinical Trials Research
Sacramento, California, United States
Northern California Research
Sacramento, California, United States
Wake Research Associates, LLC
San Diego, California, United States
Women's Healthcare Affiliates
San Diego, California, United States
CITrials, Inc
Santa Ana, California, United States
Millennium Clinical Trials
Thousand Oaks, California, United States
Women's Medical Group of Upland
Upland, California, United States
Bayview Research Group
Valley Village, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Horizons Clincial Research Center LLC
Denver, Colorado, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Emerson Clinical Research institute
Washington D.C., District of Columbia, United States
Olympian Clinical Research
Clearwater, Florida, United States
Precision Clinical Research
Coral Springs, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Florida Medical Research
Gainesville, Florida, United States
Vital Pharma Research Inc.
Hialeah, Florida, United States
Health Awareness
Jupiter, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Altus Research
Lake Worth, Florida, United States
LCC Medical Research Institute, LLC
Miami, Florida, United States
Medical Research Center of Miami II
Miami, Florida, United States
Medical Research Centers of South Florida, Inc.
Miami, Florida, United States
Florida International Research Center
Miami, Florida, United States
Spotlight research center
Miami, Florida, United States
Med Research Of Florida, LLC
Miami, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Healthcare Clinical Data Inc
North Miami, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Cornerstone Research Institute
Orlando, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Sunset Point Medical Associates
Palm Harbor, Florida, United States
Radiant Research
Pinellas Park, Florida, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Health Awareness
Port Saint Lucie, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
Premier Medical Associates
The Villages, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
NuDirections Clinical Research
Duluth, Georgia, United States
Infinite Clinical Trials
Riverdale, Georgia, United States
WR-Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Georgia Clinical Research
Snellville, Georgia, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
The Healing Sanctuary, LLC
Idaho Falls, Idaho, United States
Womens Health USA, Inc.
Champaign, Illinois, United States
Affinity Clinical Research Institute
Oak Brook, Illinois, United States
Investigators Research Group, Llc
Brownsburg, Indiana, United States
MediSphere Medical Research
Evansville, Indiana, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Avant Research Associates, LLC
Crowley, Louisiana, United States
Praetorian Pharmaceutical Research
Marrero, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Medpharmics, LLC
Metairie, Louisiana, United States
Pharmasite Research Inc
Baltimore, Maryland, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Saginaw Valley Medical Research Group, Llc
Saginaw, Michigan, United States
Montana Medical Research Inc
Missoula, Montana, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Clinical Research Center of Nevada (CRCN)
Las Vegas, Nevada, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Office Of Edmond Pack, Md
Las Vegas, Nevada, United States
Dr.R. Garn Mabey, MD,Office Of
Las Vegas, Nevada, United States
Hassman Research Institute, LLC
Berlin, New Jersey, United States
Lawrence OBGYN Associates
Lawrenceville, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Circuit Clinical
West Seneca, New York, United States
Upstate Clinical Research Associates LLC
Williamsville, New York, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Carolina women's research and wellness center
Durham, North Carolina, United States
Carolina Insitute for Clinical Research
Fayetteville, North Carolina, United States
Unified Women's Clinical Research
Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Unified Women's Clinical Research
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
CTI
Cincinnati, Ohio, United States
Greater Cincinnati OB/GYN
Cincinnati, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Complete Healthcare For Women
Columbus, Ohio, United States
Hwc Women's Research Center
Englewood, Ohio, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, United States
OB-GYN Associates
Erie, Pennsylvania, United States
The Clinical Trial Center LLC
Jenkintown, Pennsylvania, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Frontier Clinical Research
Smithfield, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Chattanooga GYN-Oncology
Chattanooga, Tennessee, United States
WR Clinsearch, LLC
Chattanooga, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Medical Research Center of Memphis, LLC
Memphis, Tennessee, United States
International Clinical Research
Murfreesboro, Tennessee, United States
Tekton Research - Georgetown
Austin, Texas, United States
Gadolin Research, LLC
Beaumont, Texas, United States
DiscoveResarch, Inc.
Bryan, Texas, United States
Advances in Health
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Protenium Clinical Research, LLC
Hurst, Texas, United States
FMC Science
Lampasas, Texas, United States
ClinRx Research
Plano, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Northeast Clinical Research Centers, Inc.
Schertz, Texas, United States
Excel Clinical Research, LLC
Sugar Land, Texas, United States
EPIC Medical Research
Murray, Utah, United States
Advanced Clinical Research-Old Farm OB/GYN (Utah)
Salt Lake City, Utah, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Site CA15005
Brampton, Ontario, Canada
Site CA15006
Burlington, Ontario, Canada
Site CA15010
Sarnia, Ontario, Canada
Site CA15007
Toronto, Ontario, Canada
Site CA15012
Lévis, Quebec, Canada
Site CA15004
Point Claire, Quebec, Canada
Site CA15002
Québec, Quebec, Canada
Site CA15009
Québec, Quebec, Canada
Site CA15003
Sherbrooke, Quebec, Canada
Site CA15001
Victoriaville, Quebec, Canada
Site CZ42008
Vodňany, Jihočeský kraj, Czechia
Site CZ42001
Olomouc, , Czechia
Site CZ42003
Olomouc, , Czechia
Site CZ42010
Písek, , Czechia
Site CZ42009
Prague, , Czechia
Site CZ42005
Tábor, , Czechia
Site LV37102
Riga, , Latvia
Site LV37101
Riga, , Latvia
Site PL48004
Bialystok, , Poland
Site PL48005
Bydgoszcz, , Poland
Site PL48002
Katowice, , Poland
Site PL48019
Katowice, , Poland
Site PL48006
Lublin, , Poland
Site PL48014
Lublin, , Poland
Site PL48016
Poznan, , Poland
Site PL48010
Szczecin, , Poland
Site PL48020
Warsaw, , Poland
Site PL48003
Warsaw, , Poland
Site PL48007
Warsaw, , Poland
Site ES34005
Centelles, , Spain
Site ES34002
Madrid, , Spain
Site UA38004
Zaporizhzhya, Zaporizhzhia Oblast, Ukraine
Site UA38006
Kiev, , Ukraine
Site GB44003
Wokingham, Berkshire, United Kingdom
Site GB44008
Sidcup, Kent, United Kingdom
Site GB44005
Corby, Northamptonshire, United Kingdom
Site GB44004
Kenilworth, Warwickshire, United Kingdom
Site GB44006
Middlesex, , United Kingdom
Site GB44007
Romford, , United Kingdom
Site GB44001
Shipley, , United Kingdom
Countries
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References
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Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, Ottery FD. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147-1164. doi: 10.1007/s12325-024-03073-8. Epub 2024 Dec 30.
Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, English M, Franklin C, Valluri U, Ottery FD. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):737-747. doi: 10.1097/AOG.0000000000005114. Epub 2023 Mar 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link Description: Link to plain language summary of the study on the Trial Results Summaries website.
Other Identifiers
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2019-000275-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2693-CL-0304
Identifier Type: -
Identifier Source: org_study_id
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