Breast Cancer Clinical Trial
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
Summary
This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study.
The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (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.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks.
This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo).
At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may 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 will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees.
The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
Full Description
This study will consist of a screening period and a 52 week treatment period. Safety follow up will occur 3 weeks after the last dose of study drug.
Eligibility Criteria
Inclusion Criteria:
Subject has a body mass index ≥ 18 kg/m^2 and ≤ 38 kg/m^2.
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 uses a prohibited therapy (strong or moderate cytochrome P450 [CYP] 1A2 inhibitors, hormone replacement therapy [HRT], hormonal contraceptive, any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
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.
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There are 172 Locations for this study
Andalusia Alabama, 36420, United States
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35235, United States
Ensley Alabama, 35218, United States
Mesa Arizona, 85209, United States
Phoenix Arizona, 85015, United States
Phoenix Arizona, 85032, United States
Tucson Arizona, 85712, United States
Tucson Arizona, 85712, United States
Tucson Arizona, 85745, United States
Canoga Park California, 91303, United States
Canoga Park California, 91304, United States
Huntington Beach California, 92647, United States
La Mesa California, 91942, United States
Los Angeles California, 90017, United States
Los Angeles California, 90057, United States
Oceanside California, 92056, United States
Sacramento California, 95821, United States
Sacramento California, 95821, United States
San Diego California, 92108, United States
San Diego California, 92111, United States
Santa Ana California, 92705, United States
Thousand Oaks California, 91360, United States
Upland California, 91786, United States
Valley Village California, 91607, United States
Denver Colorado, 80209, United States
Denver Colorado, 80220, United States
New London Connecticut, 06320, United States
Washington District of Columbia, 20011, United States
Clearwater Florida, 33757, United States
Coral Springs Florida, 33065, United States
Crystal River Florida, 34429, United States
DeLand Florida, 32720, United States
Doral Florida, 33166, United States
Fleming Island Florida, 32003, United States
Fort Myers Florida, 33912, United States
Gainesville Florida, 32607, United States
Hialeah Florida, 33016, United States
Jupiter Florida, 33458, United States
Lake City Florida, 32055, United States
Lake Worth Florida, 33461, United States
Miami Florida, 33126, United States
Miami Florida, 33134, United States
Miami Florida, 33144, United States
Miami Florida, 33174, United States
Miami Florida, 33176, United States
Miami Florida, 33186, United States
Miami Florida, 33186, United States
New Port Richey Florida, 34652, United States
North Miami Florida, 33161, United States
Ocoee Florida, 34761, United States
Orlando Florida, 32806, United States
Orlando Florida, 32806, United States
Orlando Florida, 32808, United States
Orlando Florida, 32822, United States
Ormond Beach Florida, 32174, United States
Palm Harbor Florida, 34684, United States
Pinellas Park Florida, 33781, United States
Ponte Vedra Florida, 32081, United States
Port Orange Florida, 32127, United States
Port Saint Lucie Florida, 34952, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33614, United States
The Villages Florida, 32159, United States
Winter Haven Florida, 33880, United States
Atlanta Georgia, 30328, United States
Decatur Georgia, 30030, United States
Duluth Georgia, 30096, United States
Riverdale Georgia, 30274, United States
Sandy Springs Georgia, 30328, United States
Snellville Georgia, 30078, United States
Idaho Falls Idaho, 83404, United States
Idaho Falls Idaho, 83404, United States
Champaign Illinois, 61820, United States
Oak Brook Illinois, 60523, United States
Brownsburg Indiana, 46254, United States
Evansville Indiana, 47714, United States
Wichita Kansas, 67226, United States
Crowley Louisiana, 70526, United States
Marrero Louisiana, 70072, United States
Metairie Louisiana, 70001, United States
Metairie Louisiana, 70006, United States
Baltimore Maryland, 21208, United States
Watertown Massachusetts, 02472, United States
Saginaw Michigan, 48604, United States
Missoula Montana, 59801, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89104, United States
Las Vegas Nevada, 89109, United States
Las Vegas Nevada, 89113, United States
Las Vegas Nevada, 89128, United States
Berlin New Jersey, 08009, United States
Lawrenceville New Jersey, 08648, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87109, United States
Rochester New York, 14609, United States
West Seneca New York, 14224, United States
Williamsville New York, 14221, United States
Charlotte North Carolina, 28277, United States
Durham North Carolina, 27714, United States
Fayetteville North Carolina, 28304, United States
Greensboro North Carolina, 27408, United States
Hickory North Carolina, 28601, United States
Raleigh North Carolina, 27607, United States
Raleigh North Carolina, 27612, United States
Winston-Salem North Carolina, 27103, United States
Fargo North Dakota, 58104, United States
Cincinnati Ohio, 45227, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43231, United States
Englewood Ohio, 45322, United States
North Canton Ohio, 44720, United States
Erie Pennsylvania, 16507, United States
Jenkintown Pennsylvania, 19046, United States
Philadelphia Pennsylvania, 19114, United States
Smithfield Pennsylvania, 15478, United States
Charleston South Carolina, 29406, United States
Mount Pleasant South Carolina, 29464, United States
Chattanooga Tennessee, 37404, United States
Chattanooga Tennessee, 37421, United States
Memphis Tennessee, 38119, United States
Memphis Tennessee, 38120, United States
Murfreesboro Tennessee, 37130, United States
Austin Texas, 78745, United States
Beaumont Texas, 77702, United States
Bryan Texas, 77802, United States
Houston Texas, 77030, United States
Houston Texas, 77058, United States
Hurst Texas, 76054, United States
Lampasas Texas, 76550, United States
Plano Texas, 75024, United States
San Antonio Texas, 78229, United States
Schertz Texas, 78154, United States
Sugar Land Texas, 77478, United States
Murray Utah, 84123, United States
Salt Lake City Utah, 84107, United States
Salt Lake City Utah, 84107, United States
Charlottesville Virginia, 22911, United States
Newport News Virginia, 23606, United States
Virginia Beach Virginia, 23456, United States
Seattle Washington, 98115, United States
Brampton Ontario, L6T 0, Canada
Burlington Ontario, L7M 4, Canada
Sarnia Ontario, N7T 4, Canada
Toronto Ontario, M9W 4, Canada
Levis Quebec, , Canada
Point Claire Quebec, H9R 4, Canada
Sherbrooke Quebec, J1L 0, Canada
Victoriaville Quebec, G6P 6, Canada
Quebec , G1N 4, Canada
Quebec , G1W 4, Canada
Vodnany Jihocesky, 389 0, Czechia
Olomouc , 772 0, Czechia
Olomouc , 779 0, Czechia
Pisek , 39701, Czechia
Praha 2 , 12000, Czechia
Tabor 3 , 39003, Czechia
Riga , 1005, Latvia
Riga , 1010, Latvia
Bialystok , 15-22, Poland
Bydgoszcz , 85-06, Poland
Katowice , 40-61, Poland
Katowice , 40-85, Poland
Lublin , 20-06, Poland
Lublin , 20362, Poland
Poznan , 60-19, Poland
Szczecin , 71-43, Poland
Warsaw , 02-20, Poland
Warszawa , 02-79, Poland
Warszawa , 02777, Poland
Centelles , 08540, Spain
Madrid , 28041, Spain
Zaporizhzhya Zaporizka Oblast, 69065, Ukraine
Kiev , , Ukraine
Wokingham Berkshire, RG40 , United Kingdom
Sidcup Kent, DA146, United Kingdom
Corby Northamptonshire, NN17 , United Kingdom
Kenilworth Warwickshire, CV8 1, United Kingdom
Middlesex , HA6 2, United Kingdom
Romford , , United Kingdom
Shipley , BD18 , United Kingdom
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