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.
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.
None
Women in the US who are newly initiating treatment with elizanetant
Cohort
Prospective
No intervention
Other interventionThe study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care
Socio-demographic characteristics
Menopausal status
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.
Time since menopause onset and time since onset of menopausal symptoms
Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history
Change in VMS from the baseline period to week 4 and 12
Baseline period: Time prior to first dose of elizanetant
Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire
PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b. It includes 8 items that assess self-reported sleep quality and sleep difficulties. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Number of SAE and serious TEAE
HCP reasons for prescribing elinzanetant
HCP: Health care professionals.
This trial is not recruiting at the moment. You can still explore other options:
