Набор скоро начнётся NCT07490431

An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States

— Наблюдательное Vasomotor Symptoms (VMS) Associated With Menopause

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: No intervention.
Кому может быть актуально: Состояния в реестре: Vasomotor Symptoms (VMS) Associated With Menopause. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women

Обзор

Menopause is a natural stage in a woman's life happening between ages 45 and 55. It is often associated with disruptive symptoms like hot flashes and sleep disturbances that can affect up to 8 out of 10 women and make daily life harder. Elinzanetant is a new, hormone free medicine that works by blocking certain signals in the brain that are linked to these symptoms. It has already been shown in clinical studies to help reduce hot flashes. This study is being done to learn about how elinzanetant is used, how well it works, and how safe it is for women with menopause symptoms in real-world, everyday medical care. The main goal is to understand who is starting treatment with elinzanetant and what symptoms they have. The study will also look at how well elinzanetant helps with hot flashes, night sweats, and sleep problems, how safe it is, how satisfied women are with the treatment, and how it affects their quality of life and daily activities. To do this, researchers will follow about 1,500 women in the United States who are starting elinzanetant as part of their usual care. Women will answer questions about their symptoms, sleep, and daily life using a secure app on their phone or computer. Some women will also wear a smart ring for a few weeks to collect information about their sleep. The study will last about 12 weeks for most women, but some will be followed for up to 2 years. No extra treatments or tests will be given as part of the study-researchers will only collect information about how women are doing while taking elinzanetant as prescribed by their own doctor. The results will help doctors and patients understand how elinzanetant works in real life and support better care for women going through menopause.

Вмешательства

Другое No intervention
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care

Первичные конечные точки

Socio-demographic characteristics [Срок оценки: Day 1]
Menopausal status [Срок оценки: Day 1]
Time since menopause onset and time since onset of menopausal symptoms [Срок оценки: Day 1]
Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history [Срок оценки: Day 1]
Menopausal symptoms measured by MENQOL [Срок оценки: Day 1, week 4,12 and when applicable at week 24, 52, 104]
Height [Срок оценки: Day 1, week 4 and week 12]
Weight [Срок оценки: Day 1, week 4 and week 12]

Вторичные конечные точки (12)

Change in VMS from the baseline period to week 4 and 12 [Срок оценки: Week 4 and 12]
Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire [Срок оценки: Week 4, 12 and when applicable week 24, 52 and 104]
Number of SAE and serious TEAE [Срок оценки: From Day 1 to week 12 or week 104 when applicable]
HCP reasons for prescribing elinzanetant [Срок оценки: Day 1]
Participants' satisfaction with treatment for symptoms associated with menopause [Срок оценки: Week 12 and week 52 when applicable]
Reasons for initiation, discontinuation or switching of elizanetant [Срок оценки: Week 4, week 12 and when applicable week 52]
Amount of elizanetant prescribed [Срок оценки: Week 4, week 12 and when applicable week 52]
Number of missed doses [Срок оценки: Week 4, week 12 and when applicable week 52]
Reasons for missed doses [Срок оценки: Week 4, week 12 and when applicable week 52]
Change in menopauase-related QoL [Срок оценки: Day 1 to week 4, 12 and when applicable week 24, 52 and 104]
Change in participant's affect [Срок оценки: From week 1 to week 4, 12 and when applicable to week 24, 52 and 104]
Change in work productivity and daily activity impairment [Срок оценки: From day 1 to week 4, 12 and when applicable to week 24, 52 and 104]

Критерии участия

Критерии включения

Women who newly initiate elinzanetant for treatment of menopausal VMS according to the current local label.
Signed ICF.
Ability and willingness to use study-related digital tools and to complete electronic questionnaires (ePROs), requiring access to an internet-connected device.