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New Hormone-Free drug for hot flashes tested in real life

NCT ID NCT07490431

Symptom relief Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 4 times

Summary

This study follows 1,500 women in the U.S. who are starting elinzanetant, a new hormone-free medicine for hot flashes and night sweats during menopause. Researchers will track how well it works, how safe it is, and how it affects sleep and quality of life using phone surveys and optional smart rings. The goal is to see if the benefits seen in earlier studies hold up in real-world, everyday care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elinzanetant
What this could lead to
If successful, this study could confirm that elinzanetant works well in everyday life to reduce hot flashes and improve sleep for menopausal women.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes women already prescribed the drug, and long-term effects are not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women in the US who are newly initiating treatment with elizanetant

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: • Participation in an investigational trial with interventions outside of routine clinical practice.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vasomotor symptoms (VMS) associated with menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bayer

    Whippany, New Jersey, 07981, United States

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