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. The goal of this study is to confirm if fezolinetant helps reduce hot flashes in Chinese women going through menopause. This study will also confirm the safety of fezolinetant and how well the women cope with (tolerate) the treatment. The women will take 1 tablet of the study medicine either fezolinetant or placebo once a day for up to 12 weeks. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. During the study, the women will visit the study clinic several times. At each visit they will be asked if they had any medical problems. The women will have general safety checks. At some visits, a breast ultrasound (mammogram), cervical smear, and ultrasound of the womb (uterus) may be done. The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
oral
oral
Beijing Hospital
Beijing, Beijing Municipality, China
Capital Medical University (CMU) - Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Capital Medical University - Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Guangzhou Medical University - The Third Affiliated Hospital
Guangzhou, Guangdong, China
Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 12
Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.
Time frame: Baseline to Week 12
Mean change in the frequency of moderate to severe VMS from baseline to each week up to week 12
Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.
Time frame: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Mean change in the severity of moderate to severe VMS from baseline to week 12
The severity of VMS will be calculated using a weighted average of VMS events.
Time frame: Baseline to Week 12
Mean change in the severity of moderate to severe VMS from baseline to each week up to week 12
The severity of VMS will be calculated using a weighted average of VMS events.
Time frame: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Mean percent reduction in the frequency of moderate to severe VMS from baseline to each week up to week 12
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 to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percent reduction >/= 50% in the frequency of moderate to severe VMS from baseline to each week up to week 12
Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of \>/= 50% will be reported.
Time frame: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percent reduction at 100% in the frequency of moderate to severe VMS from baseline to each week up to week 12
Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day. Percent reduction of 100% will be reported.
Time frame: Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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 in post-menopausal participants
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 up to Week 12
Number of participants with laboratory value abnormalities and/or adverse events (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 adverse events (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 Adverse Events (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
Change in serum concentrations of sex hormones
Sex hormone biomarker levels will be recorded from serum samples.
Time frame: Baseline up to Week 15
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen Maternal & Child Health Hospital
Shenzhen, Guangdong, China
Guangxi Medical University (GXMU) - Liuzhou Renmin Hospital
Liuchow, Guangxi, China
...and 17 more locations