米国における更年期症状を有する女性に対するエリンザネタントの使用状況と有効性に関する観察研究 (RELIEF)
RELIEF: 閉経後女性の血管運動症状治療におけるエリンザネタントの実世界エビデンス
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Bayer Clinical Trials Contact
- 電話番号：18888422937
- メール：clinical-trials-contact@bayer.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Women in the US who are newly initiating treatment with elizanetant
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Group 1
Elizanetant users |
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
社会人口統計学的特性
時間枠：Day 1
|
Day 1
|
|
|
閉経発症からの経過時間および更年期症状発症からの経過時間
時間枠：1日目
|
1日目
|
|
|
既往の血管運動症状（VMS）に関連する臨床歴の記述的分析
時間枠：第1日
|
第1日
|
|
|
身長
時間枠：Day 1, week 4 and week 12
|
Day 1, week 4 and week 12
|
|
|
体重
時間枠：第1日、第4週、第12週
|
第1日、第4週、第12週
|
|
|
Menopausal status
時間枠：Day 1
|
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause. |
Day 1
|
|
Menopausal symptoms measured by MENQOL
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
重篤な有害事象（SAE）および重篤な治療関連有害事象（TEAE）の数
時間枠：適用可能な場合、第1日から第12週または第104週まで
|
適用可能な場合、第1日から第12週または第104週まで
|
|
|
エリザネタントの開始、中止、または変更の理由
時間枠：第4週、第12週、および該当する場合には第52週
|
第4週、第12週、および該当する場合には第52週
|
|
|
処方されたエリザネタントの量
時間枠：4週目、12週目、および該当する場合は52週目
|
4週目、12週目、および該当する場合は52週目
|
|
|
投与回数の不足
時間枠：第4週、第12週、該当する場合は第52週
|
第4週、第12週、該当する場合は第52週
|
|
|
投与漏れの理由
時間枠：第4週、第12週、および該当する場合は第52週
|
第4週、第12週、および該当する場合は第52週
|
|
|
Change in VMS from the baseline period to week 4 and 12
時間枠：Week 4 and 12
|
Baseline period: Time prior to first dose of elizanetant |
Week 4 and 12
|
|
Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire
時間枠：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
時間枠：Day 1
|
HCP: Health care professionals. |
Day 1
|
|
Participants' satisfaction with treatment for symptoms associated with menopause
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 22958
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。