A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Inclusion Criteria

• •Subject has a body mass index ≥ 16 kg/m\^2 and ≤ 38 kg/m\^2 at screening visit.
• •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:
• •For post-menopausal subjects:
• •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)
• •For peri-menopausal subjects:
• •Skipped menstrual period with amenorrhea for ≥ 60 days but \< 6 consecutive months with biochemical criteria of peri-menopause (FSH \> 25 IU/L); or
• •Spontaneous amenorrhea for ≥ 6 months but \< 12 consecutive months with biochemical criteria of peri-menopause (FSH \> 25 IU/L and ≤ 40 IU/L)
• •* Within the 10 days prior to randomization, subject must have a minimum average of 7 mild, moderate and severe hot flashes (VMS) per day.
• •* Subject is not pregnant and at least 1 of the following conditions apply:
• •Not a woman of childbearing potential (WOCBP)
• •WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 21 days after the final study treatment administration
• •* Subject must agree not to breastfeed starting at screening and throughout the study period and for 21 days after the final study treatment administration.
• •* Subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 21 days after the final study treatment administration.
• •* 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 abnormal findings on breast imaging (obtained at screening or within the prior 12 months of screening). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant abnormal findings on breast imaging.
• •* Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and week 12 (end of treatment), and for subjects who are withdrawn from the study prior to completion, a TVU at the early discontinuation visit. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy.
• •* Subject is willing to undergo endometrial biopsy at any time during the study in the case of uterine bleeding. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy and for peri-menopausal subjects in case of menstrual bleeding.
• •* Subject has documentation of a normal or not clinically significant abnormal Pap test (or equivalent cervical cytology) within the previous 12 months of screening or at screening. This is not required for subjects who have had a full trachelectomy.
• •* Subject has a negative urine pregnancy test at screening. Urine pregnancy test is not required for female subjects who are assessed as post-menopausal status.
• •* Subject has negative serology panel (i.e. negative hepatitis B surface \[HBs\] antigen) and negative hepatitis C virus \[HCV\] antibody) at screening.
• •* Subject agrees not to participate in another interventional study while participating in the present study.