Hot Flashes
Conditions
Keywords
Menopausal symptoms, vasomotor symptoms, ESN364, fezolinetant, VEOZAH®
Brief summary
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.
Interventions
DRUGFezolinetant
Oral
Sponsors
Astellas Pharma Europe Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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. * Participant is a fluent speaker of English or French. * Participant is able to use digital devices and has access to an internet-capable device such as a mobile device or computer.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS | Up to Week 24 | 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) | Baseline, Week 4, 12, 24 and 52 | 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 | Baseline, Week 4, 12, 24 and 52 | 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 | Baseline, Week 4, 12, 24 and 52 | 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. |
| Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD) | Baseline, Week 4, 12 and 24 | 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. |
| Change from baseline in Patient Global Impression of Severity (PGI-S) SD | Baseline, Week 4, 12, 24 and 52 | The PGI-S SD evaluates patient perceived severity of hot flashes/night sweats. Ratings range from (1) no problems to (4) severe problems. |
| Change from baseline in sleep-related impairment: PROMIS SRI SF 8a raw score | Baseline, Week 4, 12, 24 and 52 | 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. |
| Change from baseline in sleep-related impairment: PROMIS SRI SF 8a total t-score | Baseline, Week 4, 12, 24 and 52 | 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. |
| Change in treatment satisfaction: Treatment Satisfaction-Visual Analog Scale (TS-VAS) | Up to Week 24 | 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. |
| Adherence of fezolinetant: Treatment Compliance-Visual Analog Scale (TC-VAS) | Up to Week 52 | 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. |
| Reasons for treatment initiation of fezolinetant | Day 1 | The reason(s) for treatment initiation will be collected. |
| Treatment discontinuation rate | Up to Week 52 | The number of participants who discontinue fezolinetant. |
| Previous therapies for VMS associated with menopause | Day 1 | Details of previous therapies for VMS will be recorded. |
| Concomitant other menopausal therapies | Up to Week 52 | Details of concomitant therapies will be recorded. |
| Number of participants with Adverse Events (AEs) | Up to Week 56 | 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. |
| Number of participants with Serious Adverse Events (SAEs) | Up to Week 56 | 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. |
| Demographics of participants initiating fezolinetant | Day 1 | Demographics of interest will be recorded. |
Countries
Canada
Contacts
CONTACTAstellas Pharma Europe Ltd.
STUDY_DIRECTORMedical Affairs
Astellas Pharma Europe Ltd.
Outcome results
None listed