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NCT Number: 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

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.

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Key information

Conditions

Vasomotor Symptoms (VMS) Associated With Menopause

Sex eligibility

Female

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care

Primary outcomes

  1. Socio-demographic characteristics

    Time frame: Day 1

  2. Menopausal status

    Time frame: Day 1

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

  3. Time since menopause onset and time since onset of menopausal symptoms

    Time frame: Day 1

  4. Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history

    Time frame: Day 1

  5. Menopausal symptoms measured by MENQOL

    Time frame: Day 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.

  6. Height

    Time frame: Day 1, week 4 and week 12

  7. Weight

    Time frame: Day 1, week 4 and week 12

Secondary outcomes

  1. Change in VMS from the baseline period to week 4 and 12

    Time frame: Week 4 and 12

    Baseline period: Time prior to first dose of elizanetant

  2. Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire

    Time frame: Week 4, 12 and when applicable week 24, 52 and 104

    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.

  3. Number of SAE and serious TEAE

    Time frame: From Day 1 to week 12 or week 104 when applicable

  4. HCP reasons for prescribing elinzanetant

    Time frame: Day 1

    HCP: Health care professionals.

  5. Participants' satisfaction with treatment for symptoms associated with menopause

    Time frame: Week 12 and week 52 when applicable

    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

  6. Reasons for initiation, discontinuation or switching of elizanetant

    Time frame: Week 4, week 12 and when applicable week 52

  7. Amount of elizanetant prescribed

    Time frame: Week 4, week 12 and when applicable week 52

  8. Number of missed doses

    Time frame: Week 4, week 12 and when applicable week 52

  9. Reasons for missed doses

    Time frame: Week 4, week 12 and when applicable week 52

  10. Change in menopauase-related QoL

    Time frame: Day 1 to week 4, 12 and when applicable week 24, 52 and 104

    Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL)

  11. Change in participant's affect

    Time frame: From week 1 to week 4, 12 and when applicable to week 24, 52 and 104

    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.

  12. Change in work productivity and daily activity impairment

    Time frame: From day 1 to week 4, 12 and when applicable to week 24, 52 and 104

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women

Acronym: RELIEF

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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