Vasomotor Symptoms (VMS) Associated With MenopauseRELIEFNCT07490431
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
An observational study of Vasomotor Symptoms (VMS) Associated With Menopause, run by Bayer.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vasomotor Symptoms (VMS) Associated With Menopause
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Nov 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women in the US who are newly initiating treatment with elizanetant
Who may be able to join
- 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.
Who cannot join
- Participation in an investigational trial with interventions outside of routine clinical practice.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women
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.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Elizanetant users Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic characteristics
Measured: Day 1
Menopausal status
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.
Measured: Day 1
Time since menopause onset and time since onset of menopausal symptoms
Measured: Day 1
Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history
Measured: Day 1
Menopausal symptoms measured by MENQOL
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.
Measured: Day 1, week 4,12 and when applicable at week 24, 52, 104
Height
Measured: Day 1, week 4 and week 12
Weight
Measured: Day 1, week 4 and week 12
Secondary outcomes (12)
Change in VMS from the baseline period to week 4 and 12
Baseline period: Time prior to first dose of elizanetant
Measured: Week 4 and 12
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.
Measured: Week 4, 12 and when applicable week 24, 52 and 104
Number of SAE and serious TEAE
Measured: From Day 1 to week 12 or week 104 when applicable
HCP reasons for prescribing elinzanetant
HCP: Health care professionals.
Measured: Day 1
Participants' satisfaction with treatment for symptoms associated with menopause
Measured by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). The MS-TSQ comprises 8 items and assesses satisfaction over the past four weeks to evaluate treatment satisfaction related to menopausal symptoms. Items are scored 1-5 on a Likert scale where 1 = very dissatisfied/not at all and 5 = very satisfied/very much
Measured: Week 12 and week 52 when applicable
Reasons for initiation, discontinuation or switching of elizanetant
Measured: Week 4, week 12 and when applicable week 52
Amount of elizanetant prescribed
Measured: Week 4, week 12 and when applicable week 52
Number of missed doses
Measured: Week 4, week 12 and when applicable week 52
Reasons for missed doses
Measured: Week 4, week 12 and when applicable week 52
Change in menopauase-related QoL
Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL)
Measured: Day 1 to week 4, 12 and when applicable 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.
Measured: From week 1 to week 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: Menopuase 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".
Measured: From day 1 to week 4, 12 and when applicable to week 24, 52 and 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor Symptoms (VMS) Associated With MenopauseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490431
- Sponsor's protocol ID
- 22958
- Acronym
- RELIEF
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.