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Not yet recruiting 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

— Observational Vasomotor Symptoms (VMS) Associated With Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Vasomotor Symptoms (VMS) Associated With Menopause. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other No intervention
    The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care

Primary outcome measures

  • Socio-demographic characteristics [Time frame: Day 1]
  • Menopausal status [Time frame: Day 1]
  • Time since menopause onset and time since onset of menopausal symptoms [Time frame: Day 1]
  • Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history [Time frame: Day 1]
  • Menopausal symptoms measured by MENQOL [Time frame: Day 1, week 4,12 and when applicable at week 24, 52, 104]
  • Height [Time frame: Day 1, week 4 and week 12]
  • Weight [Time frame: Day 1, week 4 and week 12]
Secondary outcome measures (12)
  • Change in VMS from the baseline period to week 4 and 12 [Time frame: Week 4 and 12]
  • Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire [Time frame: Week 4, 12 and when applicable week 24, 52 and 104]
  • Number of SAE and serious TEAE [Time frame: From Day 1 to week 12 or week 104 when applicable]
  • HCP reasons for prescribing elinzanetant [Time frame: Day 1]
  • Participants' satisfaction with treatment for symptoms associated with menopause [Time frame: Week 12 and week 52 when applicable]
  • Reasons for initiation, discontinuation or switching of elizanetant [Time frame: Week 4, week 12 and when applicable week 52]
  • Amount of elizanetant prescribed [Time frame: Week 4, week 12 and when applicable week 52]
  • Number of missed doses [Time frame: Week 4, week 12 and when applicable week 52]
  • Reasons for missed doses [Time frame: Week 4, week 12 and when applicable week 52]
  • Change in menopauase-related QoL [Time frame: Day 1 to week 4, 12 and when applicable week 24, 52 and 104]
  • Change in participant's affect [Time frame: From week 1 to week 4, 12 and when applicable to week 24, 52 and 104]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Bayer — Whippany

Identifiers

NCT: NCT07490431 · 22958

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗