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Идёт набор NCT07602530

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

— Наблюдательное Hot Flashes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fezolinetant.
Кому может быть актуально
Состояния в реестре: Hot Flashes. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Fezolinetant
    Oral

Первичные конечные точки

  • Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS [Срок оценки: Week 12]
Вторичные конечные точки (12)
  • Percentage of participants reporting improvement in hot flashes/night sweats: PGI-C VMS [Срок оценки: Up to Week 24]
  • Change from baseline in menopause-related quality of life due to VMS: Hot Flash Related Daily Interference Scale (HFRDIS) [Срок оценки: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep disturbance: PROMIS SD SF 8b raw score [Срок оценки: 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 [Срок оценки: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep disturbance: PGI-C sleep disturbance (SD) [Срок оценки: Baseline, Week 4, 12 and 24]
  • Change from baseline in Patient Global Impression of Severity (PGI-S) SD [Срок оценки: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep-related impairment: PROMIS SRI SF 8a raw score [Срок оценки: Baseline, Week 4, 12, 24 and 52]
  • Change from baseline in sleep-related impairment: PROMIS SRI SF 8a total t-score [Срок оценки: Baseline, Week 4, 12, 24 and 52]
  • Change in treatment satisfaction: Treatment Satisfaction-Visual Analog Scale (TS-VAS) [Срок оценки: Up to Week 24]
  • Adherence of fezolinetant: Treatment Compliance-Visual Analog Scale (TC-VAS) [Срок оценки: Up to Week 52]
  • Reasons for treatment initiation of fezolinetant [Срок оценки: Day 1]
  • Treatment discontinuation rate [Срок оценки: Up to Week 52]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 2 центра
  • Site CA15002 — Montreal
  • Site CA15001 — Prince Albert

Идентификаторы

NCT: NCT07602530 · 2693-MA-3603

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗