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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vasomotor Symptoms (VMS) Associated With Menopause
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women in the US who are newly initiating treatment with elizanetant

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Elizanetant users	Other: No intervention; The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic characteristics		Day 1
Menopausal status	Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.	Day 1
Time since menopause onset and time since onset of menopausal symptoms		Day 1
Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history		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.	Day 1, week 4,12 and when applicable at week 24, 52, 104
Height		Day 1, week 4 and week 12
Weight		Day 1, week 4 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VMS from the baseline period to week 4 and 12	Baseline period: Time prior to first dose of elizanetant	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.	Week 4, 12 and when applicable week 24, 52 and 104
Number of SAE and serious TEAE		From Day 1 to week 12 or week 104 when applicable
HCP reasons for prescribing elinzanetant	HCP: Health care professionals.	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	Week 12 and week 52 when applicable
Reasons for initiation, discontinuation or switching of elizanetant		Week 4, week 12 and when applicable week 52
Amount of elizanetant prescribed		Week 4, week 12 and when applicable week 52
Number of missed doses		Week 4, week 12 and when applicable week 52
Reasons for missed doses		Week 4, week 12 and when applicable week 52
Change in menopauase-related QoL	Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL)	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.	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".	From day 1 to week 4, 12 and when applicable to week 24, 52 and 104

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 22958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No