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Observational Study of Elinzanetant for Menopause Symptoms

This is an observational study to learn more about Elinzanetant, a hormone-free medicine for hot flashes and other menopause symptoms. Elinzanetant works by blocking certain signals in the brain linked to these symptoms. Researchers want to understand how it's used, how well it works, and its safety for women in real-world medical care. You may be able to join if you are a woman newly starting Elinzanetant for menopause symptoms, can sign an informed consent form, and are willing to use digital tools for questionnaires. The main goal is to understand who is starting Elinzanetant and what symptoms they have. The study aims to enroll 1500 women, but its current status is unclear.

Study design
This is an observational study, meaning there are no specific medical procedures beyond your usual care. It aims to include 1500 women.
What's involved
You would need to use study-related digital tools and complete electronic questionnaires (ePROs) using an internet-connected device.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, such as socio-demographic characteristics and menopausal status, are measured at Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting
Not specifiedAll AgesObservational
Bayer
~1,500 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Socio-demographic characteristics
Measured over Day 1
+6 more outcomes measured

Conditions

Vasomotor Symptoms (VMS) Associated With Menopause

Explore related trials

Vasomotor Symptoms

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Socio-demographic characteristicsDay 1
  • Menopausal statusDay 1

    Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.

  • Time since menopause onset and time since onset of menopausal symptomsDay 1
  • Descriptive analyses of prior vasomotor symptoms (VMS) related clinical historyDay 1
  • Menopausal symptoms measured by MENQOLDay 1, week 4,12 and when applicable at week 24, 52, 104

    MENQOL: Menopause-Specific Quality of Life Questionnaire. It contains 29 items questionnaire that assess presence of menopausal symptoms and how bothersome they are, across four domains: vasomotor, psychosocial, physical and sexual. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a scale with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.

  • HeightDay 1, week 4 and week 12
  • WeightDay 1, week 4 and week 12