A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
NCT ID: NCT04003142
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
501 participants
INTERVENTIONAL
2019-07-10
2021-04-23
Brief Summary
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The study treatments are fezolinetant 30 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 is a dummy treatment that looks like medicine but does not have any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes and the study evaluated if fezolinetant reduces the severity of the hot flashes.
Women in the study received an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin.
The study participants took study treatment for 52 weeks. The first 12 weeks of study treatment 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) during that time. The last 40 weeks of study treatment was "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant.
At weeks 2, 4, 8, 12, 14, 16 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 was collected for laboratory tests. Study participants completed questionnaires that were about how hot flashes affect their daily life. Study participants who had their uterus had the following 2 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. This test used sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have 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 have 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 agrees.
The last check-up at the hospital or clinic was 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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Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg
Participants received fezolinetant 30 mg (one 30 mg fezolinetant tablet and one placebo tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 30 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Fezolinetant
Oral tablet
Double-blind Period: Fezolinetant 45 mg/Extension Period: Fezolinetant 45 mg
Participants received fezolinetant 45 mg (one 30 mg tablet and one 15 mg tablet) orally, QD up to week 12 during double-blind treatment period followed by fezolinetant 45 mg orally, QD from week 13 up to Week 52 during extension treatment period.
Fezolinetant
Oral tablet
Double-blind Period: Placebo
Participants received fezolinetant matching placebo (two fezolinetant matching placebo tablets) orally, once daily (QD) up to week 12 during double-blind treatment period.
placebo
Oral Tablet
Double-blind Period: Placebo/Extension Period: Fezolinetant 30 mg
Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 30 mg orally, QD from week 13 up to week 52 during extension treatment period.
Fezolinetant
Oral tablet
Double-blind Period: Placebo/Extension Period: Fezolinetant 45 mg
Participants who received placebo during double-blind treatment period were re-randomized to receive fezolinetant 45 mg orally, QD from week 13 up to week 52 during extension treatment period.
Fezolinetant
Oral tablet
Interventions
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Fezolinetant
Oral tablet
placebo
Oral Tablet
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 \[FSH\] \> 40 IU/L); or
* Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
* Within the 10 days prior to randomization, subject must have a minimum average of 7 to 8 moderate to severe hot flashes (HFs) vasomotor symptoms (VMS) per day, or 50 to 60 per week.
* 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 electrocardiogram (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 findings mammogram (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), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation (ED) visit.
* Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT), for subjects with uterine bleeding, and for subjects who are withdrawn from the study prior to completion. 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 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 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 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m\^2 at screening.
* 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 question 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 at screening and at 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 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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Mesa Obstetricians and Gynecologists
Mesa, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Visions Clinical Research - Tuscon
Tucson, Arizona, United States
Excell Research
Oceanside, California, United States
Dream Team Clinical Research, LLC
Pomona, California, United States
Clinical Trials Research
Sacramento, California, United States
Wake Research Associates, LLC
San Diego, California, United States
Women's Healthcare Affiliates
San Diego, 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
Physicians' Research Options/Red Rocks OB/GYN
Lakewood, Colorado, United States
Helix Biomedics
Boynton Beach, Florida, United States
Renaissance Research and Medical Group, Inc.
Cape Coral, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Bioclinica Research, Melbourne
Melbourne, Florida, United States
LCC Medical Research Institute, LLC
Miami, Florida, United States
Suncoast Clinical Research, Inc.
Miami, Florida, United States
Suncoast Research
Miami, Florida, United States
Medical Health Center & Research
Miami, 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
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Physician Care Clinical Research, LLC
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
Comprehensive Clinical Development
West Palm Beach, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Georgia Research for Women
Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
WR-Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Georgia Clinical Research
Snellville, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
ASR, LLC-Advanced Specialty Research
Nampa, Idaho, United States
Affinity Clinical Research Institute
Oak Brook, Illinois, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Praetorian Pharmaceutical Research
Marrero, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Women Under Study, LLC
New Orleans, Louisiana, United States
Pharmasite Research Inc
Baltimore, Maryland, United States
Clinical Research Center of Nevada (CRCN)
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
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
Circuit Clinical
West Seneca, New York, United States
Premier Gynecology & Wellness
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Hwc Women's Research Center
Englewood, Ohio, United States
OB/GYN Associates of Erie
Erie, Pennsylvania, United States
Dr. Marvin Kalafer MD, Office Of
Jenkintown, Pennsylvania, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
The Clinical Research Center, LLC
Carrollton, Texas, United States
Advances in Health
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
FMC Science
Lampasas, Texas, United States
ClinRx Research
Plano, Texas, United States
Granger Medical Clinic
Riverton, Utah, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
North Spokane Women's Health
Spokane, Washington, United States
Site CA15006
Sarnia, Ontario, Canada
Site CA15009
Toronto, Ontario, Canada
Site CA15007
Lévis, Quebec, Canada
Site CA15002
Sherbrooke, Quebec, Canada
Site CA15001
Victoriaville, Quebec, Canada
Site CA15008
Québec, , Canada
Site CZ42007
Písek, , Czechia
Site CZ42006
Prague, , Czechia
Site CZ42004
Prague, , Czechia
Site CZ42005
Tábor, , Czechia
Site CZ42003
Vsetín, , Czechia
Site LV37101
Riga, , Latvia
Site LV37103
Riga, , Latvia
Site PL48001
Bydgoszcz, , Poland
Site PL48013
Elblag, , Poland
Site PL48009
Katowice, , Poland
Site PL48011
Krakow, , Poland
Site PL48002
Lublin, , Poland
Site PL48012
Lublin, , Poland
Site PL48004
Piaseczno, , Poland
Site PL48006
Poznan, , Poland
Site PL48005
Szczecin, , Poland
Site PL48010
Warsaw, , Poland
Site PL48003
Warsaw, , Poland
Site ES34003
Aravaca, , Spain
Site ES34002
Centelles, , Spain
Site ES34001
Madrid, , Spain
Site GB44001
Shipley, , United Kingdom
Countries
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References
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Santoro N, Neal-Perry G, Stute P, Blogg M, Mancuso S, Morga A, Ottery FD, Siddiqui E. Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy. Curr Med Res Opin. 2025 Feb;41(2):375-384. doi: 10.1080/03007995.2025.2470752. Epub 2025 Mar 5.
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.
Morga A, Zimmermann L, Valluri U, Siddiqui E, McLeod L, Bender RH. Validation and Application of Thresholds to Define Meaningful Change in Vasomotor Symptoms Frequency: Analysis of Pooled SKYLIGHT 1 and 2 Data. Adv Ther. 2024 Jul;41(7):2845-2858. doi: 10.1007/s12325-024-02849-2. Epub 2024 May 22.
Schultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric Evaluation of the MENQOL Instrument in Women Experiencing Vasomotor Symptoms Associated with Menopause. Adv Ther. 2024 Jun;41(6):2233-2252. doi: 10.1007/s12325-024-02787-z. Epub 2024 Feb 24.
Schultz NM, Morga A, Siddiqui E, Rhoten SE. Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause. Health Qual Life Outcomes. 2023 Nov 21;21(1):126. doi: 10.1186/s12955-023-02206-x.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to plain language summary of the study on the Trial Results Summaries website.
Other Identifiers
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2018-003529-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2693-CL-0302
Identifier Type: -
Identifier Source: org_study_id
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