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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fezolinetant | Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fezolinetant | Drug | Oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astellas Pharma Europe Ltd. | Contact | +1-800-888-7704 | astellas.registration@astellas.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CA15002 | Recruiting | Montreal | Canada | |||
| Site CA15001 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000608808 | fezolinetant |
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| 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. | Baseline, Week 4, 12, 24 and 52 |
| 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). | Baseline, Week 4, 12, 24 and 52 |
| 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. | Baseline, Week 4, 12, 24 and 52 |
| Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD) | PGI-C SD evaluates patient perceived change in sleep disturbance 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. | Baseline, Week 4, 12 and 24 |
| Change from baseline in Patient Global Impression of Severity (PGI-S) SD | The PGI-S SD evaluates patient perceived severity of hot flashes/night sweats. Ratings range from (1) no problems to (4) severe problems. | Baseline, Week 4, 12, 24 and 52 |
| Change from baseline in sleep-related impairment: PROMIS SRI SF 8a raw score | The PROMIS SRI SF 8a assesses sleep-related impairment over the past 7 days. It includes self-reported perceptions of waking alertness, sleepiness and function within the context of overall sleep-wake function. 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 are associated with more impaired sleep and range between 8 and 40. | Baseline, Week 4, 12, 24 and 52 |
| Change from baseline in sleep-related impairment: PROMIS SRI SF 8a total t-score | The Patient-reported Outcomes Measurement Information System Sleep-related Impairment - Short Form 8a (PROMIS SRI SF 8a) assesses sleep-related impairment over the past 7 days. It includes self-reported perceptions of waking alertness, sleepiness and function within the context of overall sleep-wake function. T-scores are raw scores rescaled with score of 50 corresponding to the population average and standard deviation of 10. | Baseline, Week 4, 12, 24 and 52 |
| Change in treatment satisfaction: Treatment Satisfaction-Visual Analog Scale (TS-VAS) | Participants will complete 1 question ("Are you satisfied with your Veozah treatment?") in the TS-VAS to assess treatment satisfaction. Provisional response options range from 0% (no, not at all) to 100% (yes, completely). The participant's response is to indicate on the line by the distance from either end how satisfied they are. | Up to Week 24 |
| Adherence of fezolinetant: Treatment Compliance-Visual Analog Scale (TC-VAS) | The TC-VAS is a VAS that asks participants to report the number of doses of fezolinetant they have actually taken from the number of doses planned as a percentage (% compliance) with a question. Provisional response options range from 0% (no, not at all) to 100% (yes, completely). The participant's response is to indicate on the line by the distance from either end how compliant they are. | Up to Week 52 |
| Reasons for treatment initiation of fezolinetant | The reason(s) for treatment initiation will be collected. | Day 1 |
| Treatment discontinuation rate | The number of participants who discontinue fezolinetant. | Up to Week 52 |
| Previous therapies for VMS associated with menopause | Details of previous therapies for VMS will be recorded. | Day 1 |
| Concomitant other menopausal therapies | Details of concomitant therapies will be recorded. | Up to Week 52 |
| Number of participants with Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a drug 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 a medicinal product whether or not considered related to the medicinal (investigational) product. | Up to Week 56 |
| Number of participants with Serious Adverse Events (SAEs) | An adverse event is considered "serious" if, in the view of either the medically qualified person or sponsor, it results in death, is life threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, or a medically important event. | Up to Week 56 |
| Demographics of participants initiating fezolinetant | Demographics of interest will be recorded. | Day 1 |
| Recruiting |
| Prince Albert |
| Canada |