미국에서 폐경 증상을 겪는 여성들에게 엘린자네탄트가 어떻게 사용되며 얼마나 효과적인지에 대한 관찰 연구 (RELIEF)
RELIEF: 폐경 후 여성의 혈관운동성 증상 치료를 위한 ELInzanEtant에 관한 실제 세계 증거
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Bayer Clinical Trials Contact
- 전화번호: 18888422937
- 이메일: clinical-trials-contact@bayer.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Women in the US who are newly initiating treatment with elizanetant
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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사회인구학적 특성
기간: 1일차
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1일차
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폐경 발병 이후 경과 시간 및 폐경 증상 발병 이후 경과 시간
기간: 1일차
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1일차
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이전 혈관운동증상(VMS) 관련 임상 병력에 대한 기술적 분석
기간: 1일차
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1일차
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키
기간: 1일차, 4주차 및 12주차
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1일차, 4주차 및 12주차
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체중
기간: 1일차, 4주차 및 12주차
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1일차, 4주차 및 12주차
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Menopausal status
기간: Day 1
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Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause. |
Day 1
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Menopausal symptoms measured by MENQOL
기간: Day 1, week 4,12 and when applicable at week 24, 52, 104
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SAE 및 심각한 TEAE 발생 건수
기간: Day 1부터 적용 가능한 경우 12주 또는 104주까지
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Day 1부터 적용 가능한 경우 12주 또는 104주까지
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엘리자네탄트의 시작, 중단 또는 전환 이유
기간: 4주차, 12주차 및 해당하는 경우 52주차
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4주차, 12주차 및 해당하는 경우 52주차
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처방된 엘리자네탄트 용량
기간: 4주차, 12주차 및 해당되는 경우 52주차
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4주차, 12주차 및 해당되는 경우 52주차
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복용 누락 횟수
기간: 4주차, 12주차 및 해당하는 경우 52주차
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4주차, 12주차 및 해당하는 경우 52주차
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복용 누락 이유
기간: 4주차, 12주차 및 해당되는 경우 52주차
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4주차, 12주차 및 해당되는 경우 52주차
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Change in VMS from the baseline period to week 4 and 12
기간: Week 4 and 12
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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
기간: Week 4, 12 and when applicable week 24, 52 and 104
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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
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HCP reasons for prescribing elinzanetant
기간: Day 1
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HCP: Health care professionals. |
Day 1
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Participants' satisfaction with treatment for symptoms associated with menopause
기간: Week 12 and week 52 when applicable
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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
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Change in menopauase-related QoL
기간: Day 1 to week 4, 12 and when applicable week 24, 52 and 104
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Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL) |
Day 1 to week 4, 12 and when applicable week 24, 52 and 104
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Change in participant's affect
기간: From week 1 to week 4, 12 and when applicable to week 24, 52 and 104
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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
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Change in work productivity and daily activity impairment
기간: From day 1 to week 4, 12 and when applicable to week 24, 52 and 104
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 22958
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
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