Phase
Condition
N/ATreatment
Placebo
Fezolinetant
Clinical Study ID
Ages 40-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has a body mass index >/= 16 kg/m2 and </= 38 kg/m2 at screening visit.
Participant must be seeking treatment or relief for vasomotor symptom(s) (VMS)associated with menopause and confirmed as menopausal per 1 of the followingcriteria 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 (with or without hysterectomy).
FSH > 40 IU/L if participants received hysterectomy but still have anovary/ovaries.
Within the 10 days prior to randomization, participant must have a minimum averageof 7 moderate to severe hot flash(es) (HFs) (VMS) per day (data must be availablefor at least 7 of the last 10 days prior to randomization).
Participant is in good general health as determined on the basis of medical historyand general physical examination, performed at the screening visit; hematology andbiochemistry parameters, pulse rate and/or blood pressure, and electrocardiogram (ECG) within the reference range for the population studied, or showing noclinically relevant deviations.
Participant has documentation of a normal/negative or no clinically significantfindings mammogram (or breast ultrasound) (e.g., < Breast Imaging-Reporting and DataSystem (BI-RADS) class 4; obtained at screening or within the prior 12 months ofstudy enrollment). Appropriate documentation includes a written report or anelectronic report indicating normal/negative or no clinically significantmammographic findings.
Participant is willing to undergo a transvaginal ultrasound (TVU) to evaluate theuterus and ovaries at screening and week 12 (end of treatment (EOT)), and forparticipants who are withdrawn from the study prior to completion, a TVU at theearly discontinuation (ED) visit. This is not required for participants who have hada partial (supracervical) or total hysterectomy.
Participant has documentation of a normal or not clinically significant Pap test (orequivalent cervical cytology) within the previous 12 months of study enrollment orat screening. This is not required for participants who have had a totalhysterectomy.
Participant has a negative urine pregnancy test at screening; this is not requiredfor participants who have had a total hysterectomy.
Participant has a negative serology panel [i.e., negative hepatitis B surfaceantigen (HBsAg) and negative hepatitis C virus antibody (HCVAb) screens] atscreening.
Participant agrees not to participate in another interventional study whileparticipating in the present study.
Exclusion
Exclusion Criteria:
Participant has known substance abuse or alcohol addiction within 6 months ofscreening.
Participant has a current malignancy, with exception of non-metastatic basal cellcarcinoma of the skin.
Participant has a history of malignancy with exceptions of at least 5 yearspost-treatment and without known recurrence.
For participants with a uterus: Participant has an unacceptable result from the TVUassessment at screening, i.e., full length of endometrial cavity cannot bevisualized or presence of a clinically significant finding.
Participant has a history within the last 6 months of undiagnosed uterine bleeding.
Participant has a medical condition or chronic disease (including history ofneurological [including cognitive], hepatic, renal, cardiovascular,gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynecologicaldisease) or malignancy that could confound interpretation of the study outcome.
Participant has a history of suicide attempt or suicidal behavior within the last 12months or has suicidal ideation within the last 12 months (a response of "yes" toquestion 4 or 5 on the suicidal ideation portion of the Columbia-Suicide SeverityRating Scale [C-SSRS]), or who is at significant risk to commit suicide at screening [visit 1].
Participant has previously been enrolled in a clinical trial with fezolinetant orother neurokinin (NK) receptor antagonists.
Participant uses a prohibited therapy (strong and moderate cytochrome P450 1A2 [CYP1A2] inhibitors, hormone replacement therapy (HRT), hormonal contraceptive orany treatment for VMS [prescription, over-the-counter, or herbal]) or is not willingto wash-out and discontinue use of such drugs for the full duration of studyconduct.
Participant has received any investigational therapy within 28 days or 5 half-lives,whichever is longer, prior to screening.
Participant has uncontrolled hypertension, defined as systolic blood pressure >/=140mmHg or diastolic blood pressure as >/= 90 mmHg based on an average of 2 to 3readings within the screening period.
Participants with a medical history of hypertension who are well controlled maybe enrolled
Participants who do not meet these criteria may be re-assessed after initiationor review of antihypertensive measures
Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated totalor direct bilirubin, elevated international normalized ratio (INR) or elevatedalkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 ×upper limit of normal (ULN) can be enrolled if total and direct bilirubin arenormal. Patients with mildly elevated ALP (up to 1.5 × ULN) can be enrolled ifcholestatic liver disease is excluded and no cause other than fatty liver isdiagnosed. Patients with Gilbert's syndrome with elevated total bilirubin (TBL) maybe enrolled as long as hemolysis is ruled-out (i.e., direct bilirubin, hemoglobinand reticulocytes are normal).
Participant has creatinine > 1.5 × ULN; or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease formula </=30 mL/min/1.73 m2at screening.
Participant has a positive result for human immunodeficiency virus (HIV) atscreening.
Participant has any condition which makes the participant unsuitable for studyparticipation.
Participant is unable or unwilling to complete the study procedures.
Participant has a known or suspected hypersensitivity to fezolinetant or anycomponents of the formulation used.
Study Design
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing
ChinaActive - Recruiting
Guangzhou Medical University - The Third Affiliated Hospital
Guangzhou, Guangdong
ChinaActive - Recruiting
The second Hospital of Hebei Medical University
Shijiazhuang, Hebei
ChinaActive - Recruiting
Jiang Maternal and Child Health Hospital
Nan Chang, Jiang XI
ChinaActive - Recruiting
Jiangxi Maternal and Child Health Hospital
Nan Chang, Jiang XI
ChinaActive - Recruiting
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