This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. It is currently approved in more than 40 countries, including the US and countries in Europe. Further studies are needed before it is approved for use in India. The aim of this study is to confirm if fezolinetant can help reduce hot flashes in Indian women. Women who want to take part in the study will be given an electronic device or use the app on their own smartphone to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. All the women in the study will take 1 tablet of fezolinetant once a day for up to 12 weeks. During the study, the women will visit the study clinic several times. The researchers will collect information about the women's health and ask about their hot flashes and night sweats. At each visit, they will also be asked if they have any medical problems. The women will have a follow up visit 3 weeks after taking their last tablet of study treatment, to collect information about their health and symptoms. Each woman will be in this study for about 5 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Oral
Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS)
Frequency of moderate and severe VMS events will be calculated as sum of moderate and severe VMS events per day.
Time frame: Baseline and week 12
Mean change from baseline in the frequency of moderate to severe VMS
Frequency of moderate and severe VMS events will be calculated as sum of moderate and severe VMS events per day.
Time frame: Baseline and up to week 12
Mean change from baseline in the severity of moderate to severe VMS
The severity of VMS will be calculated using a weighted average of VMS events.
Time frame: Baseline and up to week 12
Mean percent reduction 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. Mean percent reduction will be reported.
Time frame: Baseline and up to week 12
Percent reduction ≥ 50% in the frequency of moderate to severe VMS
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 100% in the frequency of moderate to severe VMS
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.
Time frame: Up to week 15
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinical significant laboratory values.
Time frame: Up to week 15
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinical 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 clinical 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.
Time frame: Up to week 12
PK of metabolite ES259564 in plasma: Concentration
Concentration will be recorded from the PK plasma samples.
Time frame: Up to week 12
Change in serum concentrations of sex hormones: luteinizing hormone (LH)
Concentration will be recorded from pharmacodynamics serum samples.
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: follicle-stimulating hormone (FSH)
Concentration will be recorded from pharmacodynamics serum samples.
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: estradiol (E2)
Concentration will be recorded from pharmacodynamics serum samples.
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone: testosterone
Concentration will be recorded from pharmacodynamics serum samples.
Time frame: Baseline and up to Week 15
Change in serum concentrations of sex hormone-binding globulin (SHBG)
Concentration will be recorded from pharmacodynamics serum samples.
Time frame: Baseline and up to Week 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.