This study is for menopausal women who have hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study will take place in Japan. This study will provide more information on a potential new treatment, called fezolinetant. The treatments in this study are fezolinetant or a placebo. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to find the best dose of fezolinetant to reduce the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device to track their hot flashes. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. Women will be picked for 1 of 3 treatments (lower or higher dose of fezolinetant, or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 12 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (lower or higher dose of fezolinetant, or placebo). The women will continue recording information about their hot flashes on the electronic device. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check-up. This will happen during weeks 2, 4, 8, 12 and 15. At the check-up, they will be asked if they have any medical problems. Other checks will include some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam, an ECG to check their heart rhythm, and their vital signs checked (pulse rate, temperature and blood pressure). At the first visit and in week 15, women who have a 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 check-up (at week 15) will be 3 weeks after they take their last tablets of study medicine (lower or higher dose of fezolinetant or placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
oral
oral
Juno Vesta Clinic Hatta
Matsudo-shi, Chiba, Japan
Mori Ladies Clinic
Fukuoka, Fukuoka, Japan
SANO Women's Clinic
Fukuoka, Fukuoka, Japan
Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital
Kitakyusyu-shi, Fukuoka, Japan
Ena Odori Clinic
Sapporo, Hokkaido, Japan
Kotoni Ladies Clinic
Mean change from baseline in the frequency of mild, moderate and severe vasomotor symptom (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, moderate and 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
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. 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 IP whether or not considered related to the IP.
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 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
Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.
Time frame: Up to Week 15
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