This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatment is fezolinetant (1 tablet of fezolinetant) once a day. The study participants will take study treatment for 52 weeks. At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
The study will consist of a screening period, a 52-week treatment period and a follow-up visit, 3 weeks after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Oral
Site CN86002
Beijing, China
Site CN86015
Beijing, China
Site CN86029
Beijing, China
Site CN86032
Chengdu, China
Site CN86001
Guangzhou, China
Site CN86019
Guangzhou, China
Site CN86022
Guangzhou, China
Site CN86040
Guangzhou, China
Site CN86042
Guangzhou, China
Site CN86008
Hangzhou, China
...and 19 more locations
Number of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 55 weeks
Number of Participants With Adverse Events Based on Severity
An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 55 weeks
Change From Baseline in Endometrial Thickness
Endometrial thickness is a measure of how thick the lining of the uterus is. Change from baseline will be reported.
Time frame: Baseline and 52 weeks
Percentage of Participants With Endometrial Hyperplasia and/or Endometrial Cancer
Endometrial hyperplasia is thickening of the lining of the uterus. Endometrial cancer is cancer of the lining of the uterus. Percentage of participants will be reported.
Time frame: Up to 52 weeks
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 55 weeks
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 55 weeks
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 55 weeks
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 52 weeks
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) Levels
Change from baseline in serum concentrations of BSAP will be reported.
Time frame: Baseline, week 52 and week 55
Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) Levels
Change from baseline in serum concentrations of P1NP will be reported.
Time frame: Baseline, week 52 and week 55
Change From Baseline in Carboxy-terminal Telopeptide of Type I Collagen (CTX) Levels
Change from baseline in serum concentrations of CTX will be reported.
Time frame: Baseline, week 52 and week 55
Change From Baseline in Serum Concentration of Sex Hormones
Change from baseline in serum concentration of sex hormones will be reported.
Time frame: Baseline, week 4, week 12, week 24 , week 52 and week 55
Change From Baseline in Sex Hormone-Binding Globulin (SHBG)
Change from baseline in serum concentration of SHBG will be reported.
Time frame: Baseline, week 4, week 12, week 24 , week 52 and week 55
Pharmacokinetics (PK) of Fezolinetant in Plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Week 4, week 12, week 24 and week 52
Pharmacokinetics (PK) of Fezolinetant Metabolite ES259564 in Plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Week 4, week 12, week 24 and week 52
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