Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07490431 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
NotableEnrollment increased: 1500 → 2400 participantsStudy sites: 1 to 0 · Primary and study completion dates: Nov 2, 2029 to Nov 30, 2029 · Start date: Nov 2, 2026 to Nov 30, 2026 · 2 moreShow 5 more changesShow less
Study sites: 1 to 0
Primary and study completion dates: Nov 2, 2029 to Nov 30, 2029
Start date: Nov 2, 2026 to Nov 30, 2026
Secondary endpoints: details revised at 4 of 12 entries
Eligibility criteria expanded, about 3 words
MinorRe-verified, no change to tracked fieldsv5
NotableStart date: Jun 30, 2026 to Nov 2, 2026Primary and study completion pushed from Jun 30, 2029 to Nov 2, 2029v4Show 1 more changeShow less
Primary and study completion pushed from Jun 30, 2029 to Nov 2, 2029
MinorRe-verified, no change to tracked fieldsv3
NotablePrimary and study completion pushed from Dec 1, 2027 to Jun 30, 2029Start date: Mar 31, 2026 to Jun 30, 2026v2Show 1 more changeShow less
Start date: Mar 31, 2026 to Jun 30, 2026
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.