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.
Participant has a body mass index ≥ 17 kg/m² and ≤ 38 kg/m² at screening visit.
Spontaneous amenorrhea for ≥ 12 consecutive months
Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (FSH > 40 IU/L); or
Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy).
Participant has known substance abuse or alcohol addiction within 6 months of screening.
Participant has a history of malignancy with the exception of at least 5 years post treatment and without known recurrence.
Participant has a current malignancy, with the exception of non-metastatic basal cell carcinoma of the skin.
Participant has a history within the last 6 months prior to screening of undiagnosed uterine bleeding.
Single group
Fezolinetant
DrugOral
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.
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.
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.
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.
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.
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