A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Inclusion criteria

• Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per one of the following criteria at the screening visit:

• Spontaneous amenorrhea for >= 12 consecutive months
• Spontaneous amenorrhea for >= 6 months with biochemical criterion of menopause (follicle-stimulating hormone [FSH] > 40 IU/L)
• Had bilateral oophorectomy >= 6 weeks prior to the screening visit (with or without hysterectomy)
• Participant has VMS and is unsuitable to receive hormone replacement therapy (HRT) (HRT contraindicated, HRT caution, HRT stoppers and HRT averse participants).
• Participant has a minimum average of 7 moderate to severe hot flash's (HFs) (VMS) per day as recorded in the electronic diary during the last 10 days prior to randomization.
• Participant is in good general health as determined on the basis of medical history, general physical examination, laboratory and other medical assessments.
• Participant has a negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody screens).
• Had hysterectomy without oophorectomy and who meets the biochemical criterion of menopause (FSH > 40 IU/L).

Exclusion criteria

• Participant uses a prohibited therapy for VMS (e.g., prescription, over-the-counter or herbal) prior to screening and for the duration of treatment with investigational product (IP).
• Participant has known documented substance abuse or alcohol addiction within 6 months of screening.
• Participant has history of a malignant tumor within the last 5 years, except for basal cell carcinoma.
• Participant has endometrial thickness > 8 mm on the locally read screening transvaginal ultrasound (TVU) or any clinically significant findings that that would make the participant ineligible.
• Participant has history of severe allergy, hypersensitivity or intolerance to the IP and/or any of its excipients.
• Participant has a history of seizures or other convulsive disorders unless well controlled.
• Participant has a medical condition or chronic disease (including history of neurological [including cognitive], renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
• Participant has any of the following: active liver disease, jaundice, elevated liver aminotransferases at screening (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total bilirubin (TBL) or direct bilirubin (DBL) > 1.5 × upper limit of normal (ULN), elevated International Normalized Ratio (INR) > 1.5 (unless participant is receiving anticoagulant therapy) or elevated alkaline phosphatase (ALP). Participants with mildly elevated ALT or AST up to 1.5 × ULN can be enrolled if TBL and DBL are normal. Participants with mildly elevated ALP (up to 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participants with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.
• Participant has creatinine > 1.5 × 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.
• Participant has a history of suicide attempt or suicidal behavior within the last 12 months.
• Participant has participated in another interventional study within the last 30 days prior to screening and for the duration of the study.
• Participant who has been previously enrolled in a clinical study with fezolinetant.
• Participant is unable or unwilling to complete the study procedures.
• Participant has any condition makes the participant unsuitable for study participation.