This study is for women in Canada who are in menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor has prescribed fezolinetant for hot flashes and night sweats, as part of routine health care in Canada.
In this study, women will be taking tablets of fezolinetant. This study is about recording information only. The women's own doctor decides on treatment, not the study sponsor (Astellas).
Women are taking fezolinetant every day for up to 52 weeks (1 year). The main aim is to learn if fezolinetant improves hot flashes and night sweats after 12 weeks. Other aims are to learn if fezolinetant improves hot flashes and night sweats throughout the study. This includes improved sleep and the women's wellbeing. Details are recorded on how satisfied the women are with fezolinetant and if they completed their treatment. This includes reasons for stopping treatment. Any safety issues are recorded. Details about other treatments taken before or with fezolinetant are also recorded.
Participant lives in Canada.
Participant is experiencing VMS associated with menopause.
Participant is newly prescribed fezolinetant as part of routine clinical care but has not yet initiated the first dose. The decision to prescribe fezolinetant must be made prior to and independent of study participation.
Participant has acceptable hepatic function test results within the past 3 months prior to taking the first dose as described in the fezolinetant label.
A participant will be excluded if they have contraindications as described in the fezolinetant label.
A participant will be excluded if they were previously treated with fezolinetant by a physician.
A participant will be excluded if they have been clinically diagnosed with a sleep disorder (e.g., insomnia, narcolepsy) and/or is taking medication to improve a sleep disorder not associated with VMS (i.e., a participant with sleep disturbance associated with VMS is eligible).
A participant will be excluded if they are currently participating in an interventional study or previously participated in another interventional study within 6 months of the first dose of fezolinetant.
Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
Cohort
Prospective
Fezolinetant
DrugOral
Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS
The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS
The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
Change from baseline in menopause-related quality of life due to VMS: Hot Flash Related Daily Interference Scale (HFRDIS)
The HFRDIS measures the impact of VMS on the participant's overall quality of life and specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality and enjoyment of life. Responses to each of the 10 items range from 0 (do not interfere) to 10 (completely interfere); higher numbers indicate more interference.
Change from baseline in sleep disturbance: PROMIS SD SF 8b raw score
The PROMIS SD SF 8b assesses self-reported sleep disturbance over the previous 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).
Change from baseline in sleep disturbance: Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) total t-score
The PROMIS SD SF 8b assesses self-reported sleep disturbance over the previous 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. T-scores are raw scores rescaled with score of 50 corresponding to the population average and standard deviation of 10.
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