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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 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

238

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
      • Montreal, Canada
        • Recrutement
        • Site CA15002
      • Prince Albert, Canada
        • Recrutement
        • Site CA15001

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Fezolinetant
Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
Médicament: Fézolinétant
Oral
Autres noms:
  • ESN364
  • Véozah

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: Day 1
The reason(s) for treatment initiation will be collected.
Day 1
Treatment discontinuation rate
Délai: Up to Week 52
The number of participants who discontinue fezolinetant.
Up to Week 52
Previous therapies for VMS associated with menopause
Délai: Day 1
Details of previous therapies for VMS will be recorded.
Day 1
Concomitant other menopausal therapies
Délai: Up to Week 52
Details of concomitant therapies will be recorded.
Up to Week 52
Number of participants with Adverse Events (AEs)
Délai: 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)
Délai: 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
Délai: Day 1
Demographics of interest will be recorded.
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Astellas Pharma Europe Ltd.

Les enquêteurs

  • Directeur d'études: Medical Affairs, Astellas Pharma Europe Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 octobre 2025

Achèvement primaire (Estimé)

28 février 2027

Achèvement de l'étude (Estimé)

30 novembre 2027

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2693-MA-3603

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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/.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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