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A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice (CANDLELIGHT)

14 maja 2026 zaktualizowane przez: Astellas Pharma Europe Ltd.

A Real-world Observational Study of Outcomes Among Canadian Women With Bothersome VMS Associated With Menopause Who Are Treated With Fezolinetant in a Real-life Setting According to Routine Healthcare Practice

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

238

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
      • Montreal, Kanada
        • Rekrutacyjny
        • Site CA15002
      • Prince Albert, Kanada
        • Rekrutacyjny
        • Site CA15001

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Fezolinetant
Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
Lek: Fezolinetant
Doustny
Inne nazwy:
  • ESN364
  • VEOZAH

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS
Ramy czasowe: 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.
Week 12

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS
Ramy czasowe: 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.
Up to Week 24
Change from baseline in menopause-related quality of life due to VMS: Hot Flash Related Daily Interference Scale (HFRDIS)
Ramy czasowe: 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.
Baseline, Week 4, 12, 24 and 52
Change from baseline in sleep disturbance: PROMIS SD SF 8b raw score
Ramy czasowe: 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).
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
Ramy czasowe: 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.
Baseline, Week 4, 12, 24 and 52
Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD)
Ramy czasowe: 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.
Baseline, Week 4, 12 and 24
Change from baseline in Patient Global Impression of Severity (PGI-S) SD
Ramy czasowe: 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.
Baseline, Week 4, 12, 24 and 52
Change from baseline in sleep-related impairment: PROMIS SRI SF 8a raw score
Ramy czasowe: 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.
Baseline, Week 4, 12, 24 and 52
Change from baseline in sleep-related impairment: PROMIS SRI SF 8a total t-score
Ramy czasowe: 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.
Baseline, Week 4, 12, 24 and 52
Change in treatment satisfaction: Treatment Satisfaction-Visual Analog Scale (TS-VAS)
Ramy czasowe: 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.
Up to Week 24
Adherence of fezolinetant: Treatment Compliance-Visual Analog Scale (TC-VAS)
Ramy czasowe: 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.
Up to Week 52
Reasons for treatment initiation of fezolinetant
Ramy czasowe: Day 1
The reason(s) for treatment initiation will be collected.
Day 1
Treatment discontinuation rate
Ramy czasowe: Up to Week 52
The number of participants who discontinue fezolinetant.
Up to Week 52
Previous therapies for VMS associated with menopause
Ramy czasowe: Day 1
Details of previous therapies for VMS will be recorded.
Day 1
Concomitant other menopausal therapies
Ramy czasowe: Up to Week 52
Details of concomitant therapies will be recorded.
Up to Week 52
Number of participants with Adverse Events (AEs)
Ramy czasowe: 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.
Up to Week 56
Number of participants with Serious Adverse Events (SAEs)
Ramy czasowe: 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.
Up to Week 56
Demographics of participants initiating fezolinetant
Ramy czasowe: Day 1
Demographics of interest will be recorded.
Day 1

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Astellas Pharma Europe Ltd.

Śledczy

  • Dyrektor Studium: Medical Affairs, Astellas Pharma Europe Ltd.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 października 2025

Zakończenie podstawowe (Szacowany)

28 lutego 2027

Ukończenie studiów (Szacowany)

30 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

14 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2693-MA-3603

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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/.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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