Vasomotor Symptoms (VMS) Associated With Menopause
Conditions
Brief summary
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
OTHERNo intervention
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Socio-demographic characteristics | Day 1 | — |
| Menopausal status | Day 1 | Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause. |
| 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 | 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. |
| Height | Day 1, week 4 and week 12 | — |
| Weight | Day 1, week 4 and week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VMS from the baseline period to week 4 and 12 | Week 4 and 12 | Baseline period: Time prior to first dose of elizanetant |
| Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire | 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. |
| Number of SAE and serious TEAE | From Day 1 to week 12 or week 104 when applicable | — |
| HCP reasons for prescribing elinzanetant | Day 1 | HCP: Health care professionals. |
| Participants' satisfaction with treatment for symptoms associated with menopause | 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 |
| 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 | Day 1 to week 4, 12 and when applicable week 24, 52 and 104 | Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL) |
| Change in participant's affect | 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. |
| Change in work productivity and daily activity impairment | 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". |
Countries
United States
Contacts
CONTACTBayer Clinical Trials Contact
Outcome results
None listed