pause_circle_filledNot Yet Recruiting

Vasomotor symptoms (VMS) associated with menopause

Bayer Identifier:
22958
ClinicalTrials.gov Identifier:
NCT07490431
EudraCT Number:
Not Available
EU CT Number:
Not Available
An observational study to learn more about how elinzanetant is used and how well it works for women with menopause symptoms in United States

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
    • 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.
    • Participation in an investigational trial with interventions outside of routine clinical practice.

Trial summary

Enrollment Goal
1500
Trial Dates
March 2026 - December 2027
Phase
N/A
Could I Receive a placebo
No
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
BayerWhippany, 07981, US

Primary Outcome

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

Secondary Outcome

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

Trial design

RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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