An observational study in Vasomotor Symptoms (VMS) Associated With Menopause, sponsored by Bayer. Not yet recruiting at 2 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Bayer · Observational
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 signal ways 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.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 12, 2026. See what changed
Women who are newly initiating treatment with elizanetant
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elizanetant users
Other: No intervention
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care
Change in hot flash occurrence
Participants will record this information in a modified Hot Flash Diary (mHFD) and in a modified Hot Flash Daily Diary (mHFDD).
Time frame: From baseline to week 12 and when applicable until week 104.
Change in hot flash bother
Participants will record this information in a mHFD and in a mHFDD.
Time frame: From baseline to week 12 and when applicable until week 104.
Interference of hot flashes with overall daily life activities
Participants will record their information in a Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: Baseline visit, week 4, 12 and when applicable, at week 24, 52 and 104.
Change in participant's affect
Measured by Positive and Negative Affect Schedule - Short Form (PANAS-SF). PANAS-SF Comprises 10 items evaluating how frequently individuals experience positive and negative affect. Items are scored in a 1-5 Likert scale where 1 = Very slightly or not at all and 5 = Extremely.
Time frame: Baseline visit, week 4, 12 and when applicable, at week 24, 52 and 104.
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.
Time frame: Baseline visit to week 1, 2, 3, 4, 12 and when applicable, to week 24, 52 and 104.
Change in work productivity and daily activity impairment
Measured by menopause-related Work Productivity and Activity Impairment (WPAI: Menopause). WPAI: Menopause consists of 6 items assessing employment status, work hours, absenteeism, presenteeism (on-the-job productivity), and the impact of menopausal symptoms on both work and nonwork daily activities. Items are scored as yes/no or ranked from 0 "no effect" to 10 "completely affected".
Time frame: Baseline visit, week 4, 12 and when applicable, to week 24, 52 and 104.
Number of SAE and serious TEAE
Time frame: From Day 1 to week 12 or week 104 when applicable
Summary of demographic characteristics
Time frame: Baseline visit
Clinical description history of hot flashes
Time frame: Baseline visit
Number of participants who stop taking elinzanetant
Time frame: From baseline to week 12.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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