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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 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

238

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Canadá
      • Montreal, Canadá
        • Reclutamiento
        • Site CA15002
      • Prince Albert, Canadá
        • Reclutamiento
        • Site CA15001

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Fezolinetant
Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
Droga: Fezolinetante
Oral
Otros nombres:
  • ESN364
  • VEOZAH

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS
Periodo de tiempo: 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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Astellas Pharma Europe Ltd.

Investigadores

  • Director de estudio: Medical Affairs, Astellas Pharma Europe Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de octubre de 2025

Finalización primaria (Estimado)

28 de febrero de 2027

Finalización del estudio (Estimado)

30 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2693-MA-3603

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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/.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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