Een observationele studie om meer te leren over het gebruik van Elinzanetant en hoe goed het werkt voor vrouwen met overgangsklachten in de Verenigde Staten (RELIEF)
RELIEF: Real World Evidence over ELInzanEtant voor de Behandeling van Vasomotorische Symptomen bij Postmenopauzale Vrouwen
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Bayer Clinical Trials Contact
- Telefoonnummer: 18888422937
- E-mail: clinical-trials-contact@bayer.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Women in the US who are newly initiating treatment with elizanetant
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Group 1
Elizanetant users |
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sociaal-demografische kenmerken
Tijdsspanne: Dag 1
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Dag 1
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Tijd sinds het begin van de menopauze en tijd sinds het begin van menopauzale symptomen
Tijdsspanne: Dag 1
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Dag 1
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Beschrijvende analyses van eerdere klinische geschiedenis met betrekking tot vasomotorische symptomen (VMS)
Tijdsspanne: Dag 1
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Dag 1
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Hoogte
Tijdsspanne: Dag 1, week 4 en week 12
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Dag 1, week 4 en week 12
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Gewicht
Tijdsspanne: Dag 1, week 4 en week 12
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Dag 1, week 4 en week 12
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Menopausal status
Tijdsspanne: Day 1
|
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause. |
Day 1
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Menopausal symptoms measured by MENQOL
Tijdsspanne: 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. |
Day 1, week 4,12 and when applicable at week 24, 52, 104
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Aantal SAE en ernstige TEAE
Tijdsspanne: Van dag 1 tot week 12 of week 104 indien van toepassing
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Van dag 1 tot week 12 of week 104 indien van toepassing
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Redenen voor initiatie, discontinuatie of overschakeling van elizanetant
Tijdsspanne: Week 4, week 12 en indien van toepassing week 52
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Week 4, week 12 en indien van toepassing week 52
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Hoeveelheid elizanetant voorgeschreven
Tijdsspanne: Week 4, week 12 en indien van toepassing week 52
|
Week 4, week 12 en indien van toepassing week 52
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Aantal gemiste doses
Tijdsspanne: Week 4, week 12 en indien van toepassing week 52
|
Week 4, week 12 en indien van toepassing week 52
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Redenen voor gemiste doses
Tijdsspanne: Week 4, week 12 en indien van toepassing week 52
|
Week 4, week 12 en indien van toepassing week 52
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Change in VMS from the baseline period to week 4 and 12
Tijdsspanne: Week 4 and 12
|
Baseline period: Time prior to first dose of elizanetant |
Week 4 and 12
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Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire
Tijdsspanne: 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. |
Week 4, 12 and when applicable week 24, 52 and 104
|
|
HCP reasons for prescribing elinzanetant
Tijdsspanne: Day 1
|
HCP: Health care professionals. |
Day 1
|
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Participants' satisfaction with treatment for symptoms associated with menopause
Tijdsspanne: 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 |
Week 12 and week 52 when applicable
|
|
Change in menopauase-related QoL
Tijdsspanne: Day 1 to week 4, 12 and when applicable week 24, 52 and 104
|
Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL) |
Day 1 to week 4, 12 and when applicable week 24, 52 and 104
|
|
Change in participant's affect
Tijdsspanne: 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. |
From week 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
|
Change in work productivity and daily activity impairment
Tijdsspanne: 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". |
From day 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 22958
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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