pause_circle_filledNot Yet Recruiting
Vasomotor symptoms (VMS) associated with menopause
Bayer Identifier:
22958
ClinicalTrials.gov Identifier:
Not Available
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
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
1500Trial Dates
March 2026 - December 2027Phase
N/ACould I Receive a placebo
NoProducts
Lynkuet (Elinzanetant, BAY3427080)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Not yet recruiting | Bayer | Whippany, 07981, US |
Primary Outcome
- Socio-demographic characteristicsdate_rangeTime Frame:Initial visit
- Physiological characteristicsdate_rangeTime Frame:Initial visit, week 4 and week 12
- Prior VMS-related clinical history and clinical characteristicsVMS: Vasomotor symptomsdate_rangeTime Frame:Initial visit
- Menopausal symptomsdate_rangeTime Frame:Initial visit, week 4,12 and when applicable at week 24, 52, 104
- Anthropometic characteristicsdate_rangeTime Frame:Initial visit, week 4 and week 12
Secondary Outcome
- Change in VMS from the baseline period to week 4 and 12Baseline period: Time prior to first dose of elizanetantdate_rangeTime Frame:Week 4 and 12
- Change in sleep disturbances from the initial visit to week 4, 12, and, when applicable, to week 24, 52, and 104date_rangeTime Frame:Week 4, 12 and when applicable week 24, 52 and 104
- Number of SAE and serious TEAEdate_rangeTime Frame:From Initial visit to week 12 or week 104 when applicable
- HCP reasons for prescribing elinzanetantHCP: Health care professionals.date_rangeTime Frame:Initial visit
- Participants' satisfaction with treatment for symptoms associated with menopauseMeasured by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)date_rangeTime Frame:Week 12 and week 52 when applicable
- Characterization of elizanetant medication usagedate_rangeTime Frame:Week 4, week 12 and when applicable week 52
- Change in menopuase-related QoLMeasured by Menopause-Specific Quality of Life Questionnaire (MENQOL)date_rangeTime Frame:Initial visit to week 4, 12 and when applicable week 24, 52 and 104
- Change in participant's affectMeasured by Positive and Negative Affect Schedule – Short Form (PANAS-SF)date_rangeTime Frame:From Initial week to week 4, 12 and when applicable to week 24, 52 and 104
- Change in work productivity and daily activity impairmentMeasured by menopause-related Work Productivity and Activity Impairment (WPAI: Menopause)date_rangeTime Frame:From initial visit to week 4, 12 and when applicable to week 24, 52 and 104
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A