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NCT07490431 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Bayer.

Not yet
Registry status
1,500
Enrollment target

NCT07490431: Clinical Trial study, sponsored by Bayer.

NCT07490431 is a clinical trial that has not yet begun recruiting, run by Bayer. The registered enrollment target is 1,500 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07490431 has not yet begun recruiting, sponsored by Bayer.

NOT YET RECRUITING
Registry status
1,500 participants
Enrollment target

Study Summary

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.

Interventions

  • OTHER No intervention

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2026-11-02
Est. Completion 2029-11-02
Bayer

591 total trials

What is known before NCT07490431 opens enrollment

NCT07490431 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.

NCT07490431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07490431 about?

NCT07490431 is a clinical study titled "An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States". 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 bloc...

What is the current status of trial NCT07490431?

This trial is currently not yet recruiting. The enrollment target is 1,500 participants. The study started on 2026-11-02. Estimated completion is 2029-11-02.

What interventions are being tested in trial NCT07490431?

The interventions under investigation include: No intervention (OTHER).

Who is sponsoring clinical trial NCT07490431?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT07490431, the US trial registry maintained by the National Library of Medicine. NCT07490431 (large enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.