Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed. Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia. This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. Before the women are assigned a treatment, they will record information about their hot flashes. Women will either take a lower or higher dose of fezolinetant, or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it. The women will take 2 tablets of the study medicine (lower or higher dose of fezolinetant, or the placebo) once a day for up to 12 weeks. They will either take 1 tablet of fezolinetant (higher or lower dose) and 1 placebo tablet, or they will take 2 placebo tablets. The women will continue to record information about their hot flashes on the electronic device or their smartphone. During the study, the women will visit the study clinic a few times. At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life. Other checks will include a medical examination, vital signs (temperature, blood pressure and pulse). Some blood and urine samples will be taken for laboratory tests. At some visits, the women will also have an ECG to check their heart rhythm. Women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last clinic visit will be 3 weeks after the women take their final tablets of the study medicine (1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet, or 2 placebo tablets).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
410
oral
oral
Chita Kosei Hospital
Chita-gun, Aichi-ken, Japan
Konan Kosei Hospital
Kōnan, Aichi-ken, Japan
Daido Clinic
Nagoya, Aichi-ken, Japan
MEITETSU Hospital
Nagoya, Aichi-ken, Japan
Toyota Kosei Hospital
Toyota-shi, Aichi-ken, Japan
Chiba Aoba Municipal Hospital
Mean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS)
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day.
Time frame: Baseline and Week 8
Mean change from baseline in the frequency of mild to severe VMS
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day.
Time frame: Baseline and up to Week 12
Mean change from baseline in the frequency of moderate to severe VMS
Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
Time frame: Baseline and up to Week 12
Mean percent reduction in the frequency of mild to severe VMS from baseline
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Mean percent reduction will be reported.
Time frame: Baseline and up to Week 12
Mean percent reduction in the frequency of moderate to severe VMS from baseline
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Mean percent reduction will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of >/= 50% in the frequency of mild to severe VMS from baseline
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of \>/= 50% will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of >/= 75% in the frequency of mild to severe VMS from baseline
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of \>/= 75% will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of 100% in the frequency of mild to severe VMS from baseline
Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of 100% will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of >/= 50% in the frequency of moderate to severe VMS from baseline
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of \>/= 50% will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of >/= 75% in the frequency of moderate to severe VMS from baseline
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of \>/= 75% will be reported.
Time frame: Baseline and up to Week 12
Percent reduction of 100% in the frequency of moderate to severe VMS from baseline
Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of 100% will be reported.
Time frame: Baseline and up to Week 12
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Time frame: Up to Week 15
Change from baseline in endometrial thickness
Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU).
Time frame: Baseline and up to Week 12
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Week 15
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Week 15
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Time frame: Up to Week 12
Pharmacokinetics (PK) of fezolinetant in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to Week 12
Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to Week 12
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