Menopause: The Journal of The North American Menopause Society最新文献

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Intrauterine devices, contraception, and mood changes: what to watch for. 宫内节育器,避孕和情绪变化:要注意什么。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-05-01 DOI: 10.1097/GME.0000000000002742
Claudio N Soares
{"title":"Intrauterine devices, contraception, and mood changes: what to watch for.","authors":"Claudio N Soares","doi":"10.1097/GME.0000000000002742","DOIUrl":"10.1097/GME.0000000000002742","url":null,"abstract":"<p><p>Endogenous hormone changes can, for some women, contribute to mood fluctuations and the emergence of anxiety throughout the reproductive life cycle, negatively affecting well-being and functioning. Similarly, the use of hormone-based therapies-whether for contraceptive purposes, hormone suppression, or managing menopause-related symptoms-may be associated with psychological adverse effects, including irritability, depressed mood, and anxiety. Clinicians should be prepared to address these issues when discussing different contraceptive methods and when considering the efficacy, safety, and tolerability of various hormone-based treatments.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":"611-613"},"PeriodicalIF":3.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147284412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cardiometabolic changes in the menopause transition. 绝经过渡期的心脏代谢变化。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-05-01 DOI: 10.1097/GME.0000000000002775
Chrisandra Shufelt
{"title":"Cardiometabolic changes in the menopause transition.","authors":"Chrisandra Shufelt","doi":"10.1097/GME.0000000000002775","DOIUrl":"https://doi.org/10.1097/GME.0000000000002775","url":null,"abstract":"","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":"33 5","pages":"608-610"},"PeriodicalIF":3.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13105580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147776044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Short-term vocal outcomes of semioccluded vocal tract exercises in postmenopausal teachers. 绝经后教师半封闭声道练习的短期发声效果。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-05-01 DOI: 10.1097/GME.0000000000002700
Arpitha M Aji, Bennet E Joseph
{"title":"Short-term vocal outcomes of semioccluded vocal tract exercises in postmenopausal teachers.","authors":"Arpitha M Aji, Bennet E Joseph","doi":"10.1097/GME.0000000000002700","DOIUrl":"10.1097/GME.0000000000002700","url":null,"abstract":"<p><strong>Objectives: </strong>To estimate the short-term vocal outcomes of semioccluded vocal tract exercise in postmenopausal teachers.</p><p><strong>Methods: </strong>Twenty-three postmenopausal teachers meeting the inclusion and exclusion criteria were recruited for the study, out of which three were lost to follow-up. The participants underwent baseline voice assessment using acoustic measures, aerodynamic measures, and perceptual measures. The participants completed eight face-to-face semioccluded vocal tract exercise sessions during the first month, comprising humming, lip and tongue trills, and straw phonation with and without water resistance. Daily home practice was also carried out over 3 months. Follow-up assessments were conducted at the end of 1 month and 3 months from the baseline assessment to estimate the changes in parameters over the intervention duration of 3 months.</p><p><strong>Results: </strong>Postintervention assessment indicated improvement in all the parameters with statistically significant changes in jitter, shimmer, mean pitch, mean intensity, and harmonics-to-noise ratio ( P <0.05), all showing strong effect sizes. There was also a notable improvement in the Acoustic Voice Quality Index ( P =0.050) and maximum phonation duration ( P =0.053). Cepstral peak prominence and s/z ratio showed no significant changes. Grade in GRBAS (grade, roughness, breathiness, asthenia, strain) rating showed a significant difference ( P =0.039). Further, the Voice-Related Quality of Life scores improved significantly from pretherapy to post-therapy.</p><p><strong>Conclusion: </strong>The findings suggest that semioccluded vocal tract exercise, supported by structured sessions and consistent home practice, is effective in improving vocal outcomes in postmenopausal teachers. It serves as an effective therapeutic approach for addressing postmenopausal vocal changes in teachers who are not under hormone therapy.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":"544-552"},"PeriodicalIF":3.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145715007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The relationship between hot flash beliefs and insomnia symptoms in menopausal women. 更年期妇女潮热信念与失眠症状的关系
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-05-01 DOI: 10.1097/GME.0000000000002697
Daisy Caizaguano, Clara Law, Kathleen Gunthert, Evelyn Behar
{"title":"The relationship between hot flash beliefs and insomnia symptoms in menopausal women.","authors":"Daisy Caizaguano, Clara Law, Kathleen Gunthert, Evelyn Behar","doi":"10.1097/GME.0000000000002697","DOIUrl":"10.1097/GME.0000000000002697","url":null,"abstract":"<p><strong>Objective: </strong>Hot flashes are a hallmark symptom of menopause and are often implicated in sleep disturbance. Although hot flash severity has been linked to insomnia, the cognitive model of hot flashes suggests that negative beliefs about hot flashes may also influence symptom perception and distress. However, the relationship between hot flash beliefs and insomnia remains understudied. We examined whether hot flash beliefs are uniquely associated with insomnia symptom severity.</p><p><strong>Methods: </strong>This study is a cross-sectional design utilizing secondary data from participants recruited for a longitudinal study. A total of 102 perimenopausal and postmenopausal women were included in this study. Participants completed measures assessing hot flash severity, hot flash beliefs, and insomnia symptom severity. Hierarchical linear regression was used to examine whether hot flash beliefs were associated with insomnia symptoms above and beyond hot flash severity.</p><p><strong>Results: </strong>Hot flash beliefs were positively associated with insomnia symptom severity (β=0.12, P< 0.05), accounting for 24% of the variance. When hot flash severity was added to the model, both hot flash severity (β=0.80, P< 0.05) and hot flash beliefs (β=0.10, P< 0.05) were significantly positively associated with insomnia symptoms. Together, hot flash severity and hot flash beliefs explained 27% of the variance in insomnia symptom severity.</p><p><strong>Conclusion: </strong>Cognitive appraisals of hot flashes are associated with greater insomnia symptom severity in perimenopausal and postmenopausal women. It is possible that negative beliefs about hot flashes may heighten arousal and interfere with sleep, independent of hot flash severity. These findings have implications for cognitive-behavioral interventions targeting insomnia and vasomotor symptoms in this population.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":"553-558"},"PeriodicalIF":3.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145768423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utilization of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms of menopause in a real-world setting. 在现实世界中,非唑啉奈坦用于治疗更年期中重度血管舒缩症状。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-05-01 DOI: 10.1097/GME.0000000000002703
Christine D Hsu, Rebecca M Carpenter, Gwyn Richardson, Fangjian Guo, Victor Adekanmbi, Thao N Hoang, Abbey B Berenson
{"title":"Utilization of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms of menopause in a real-world setting.","authors":"Christine D Hsu, Rebecca M Carpenter, Gwyn Richardson, Fangjian Guo, Victor Adekanmbi, Thao N Hoang, Abbey B Berenson","doi":"10.1097/GME.0000000000002703","DOIUrl":"10.1097/GME.0000000000002703","url":null,"abstract":"<p><strong>Objective: </strong>Fezolinetant (Veozah) was approved as a nonhormone treatment for moderate-to-severe vasomotor symptoms of menopause in May 2023, providing a novel treatment option for women with contraindications to menopausal hormone therapy. The objective of the study was to characterize the uptake and utilization of fezolinetant in a real-world setting.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using TriNetX data, which includes 108 health care organizations and over 156 million patients. Females with an initial prescription for fezolinetant between May 1, 2023, and December 31, 2024, were included. We described baseline clinical and demographic characteristics and assessed the uptake of fezolinetant over time.</p><p><strong>Results: </strong>Our cohort included 9,853 women, including 1,315 (13.3%) who were over the age of 65 and 2,022 (20.5%) with a breast cancer diagnosis. Among the 7,222 individuals with at least 3 months of continuous enrollment, 1,477 (20.5%) had persistent use, defined as having a second fezolinetant prescription between 28 and 90 days of the initial fezolinetant prescription. Among persistent users, 42% received liver function testing in the 3 months after initiating fezolinetant, though regular monitoring is required after starting treatment. The total number of fezolinetant prescriptions increased over time, from 233 prescriptions between May 1 through July 31, 2023, to 1,871 prescriptions between May 1 and July 31, 2024.</p><p><strong>Conclusions: </strong>Our findings highlight a need for future postmarketing safety and effectiveness studies, especially among survivors of breast cancer and women 65 years and older, who were excluded from the randomized controlled trials.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":"529-535"},"PeriodicalIF":3.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12948302/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mixed methods research to support the development of an evidence-based intervention for cognitive symptoms in menopause transition. 支持以证据为基础的绝经期认知症状干预发展的混合方法研究
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-04-21 DOI: 10.1097/GME.0000000000002796
Danielle Proctor, Myra S Hunter, Lexi He, Aimee Spector
{"title":"Mixed methods research to support the development of an evidence-based intervention for cognitive symptoms in menopause transition.","authors":"Danielle Proctor, Myra S Hunter, Lexi He, Aimee Spector","doi":"10.1097/GME.0000000000002796","DOIUrl":"https://doi.org/10.1097/GME.0000000000002796","url":null,"abstract":"<p><strong>Objectives: </strong>To explore cognitive difficulties experienced during the menopause transition, and preferences for a future psychosocial intervention to support these symptoms.</p><p><strong>Methods: </strong>Mixed-methods study involving an online survey and focus groups with questions around participants' experiences of cognitive difficulties, support, and intervention development. Study posters were promoted through menopause support organizations and the University College London Menopause Mind Lab. Participants were perimenopausal and postmenopausal women, aged 40-60, with self-reported cognitive difficulties.</p><p><strong>Results: </strong>Two hundred sixteen peri and postmenopausal women (average age: 51.8 y) participated in the online survey, and 16 in focus groups. Survey data suggested that 93% of participants rated their cognitive difficulties as bothering them mildly to severely, and many felt they needed additional support. Of the participants, 95% expressed an interest in attending a new intervention, with a mix of opinions regarding the practical aspects. There was a preference for the content to include psychoeducation and teaching of strategies, as well as peer and emotional support. For the focus groups, thematic analysis generated ten main themes across two sections. For the experience of menopause, these included: support, menopause awareness, emotional impact, impact on functioning, and menopause symptoms. For the intervention development, these included: impact, content, barriers, cultural considerations, and group characteristics and format.</p><p><strong>Conclusions: </strong>Study findings demonstrate the need for a psychosocial intervention for cognitive difficulties experienced during menopause. Data from this study will inform the development of an intervention, and further research should focus on testing its feasibility and effectiveness within this population.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147776031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Age-specific and menopause-specific associations between BMI change and the risk of cervical and ovarian cancers: a population-based cohort study. BMI变化与宫颈癌和卵巢癌风险之间的年龄特异性和绝经特异性关联:一项基于人群的队列研究
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-04-21 DOI: 10.1097/GME.0000000000002767
Su Youn Nam, Junwoo Jo
{"title":"Age-specific and menopause-specific associations between BMI change and the risk of cervical and ovarian cancers: a population-based cohort study.","authors":"Su Youn Nam, Junwoo Jo","doi":"10.1097/GME.0000000000002767","DOIUrl":"https://doi.org/10.1097/GME.0000000000002767","url":null,"abstract":"<p><strong>Objectives: </strong>The association between longitudinal body mass index (BMI) change and the risk of cervical and ovarian cancers remains uncertain. We assessed those associations, evaluating modification by age and menopausal status.</p><p><strong>Methods: </strong>We conducted a population-based cohort study of 1.464 million women who completed national health examinations in 2009 and 2013 and were followed through 2017. BMI was categorized using the Asia-Pacific criteria, and 2009-2013 BMI changes were classified into 25 groups.</p><p><strong>Results: </strong>During 12,661,743 person-years, 975 cervical and 1,570 ovarian cancers occurred. Excessive BMI gain from normal to obesity I was associated with increased cervical cancer risk (adjusted hazard ratio [aHR], 3.41; 95% CI: 1.73-6.72), particularly among postmenopausal women. BMI gain from underweight to normal was linked to elevated ovarian cancer risk. BMI change showed heterogeneous associations with ovarian cancer risk, with associations differing by age group. Persistent overweight (aHR: 0.79; 95% CI: 0.65-0.95) and obesity I (aHR: 0.68; 95% CI: 0.57-0.81) was associated with reduced ovarian cancer risk in women below 60 years, whereas BMI gain from normal to obesity I (aHR: 3.23; 95% CI: 1.30-8.04), persistent overweight (aHR: 1.60; 95% CI: 1.14-2.30) and obesity I (aHR: 1.45; 95% CI: 1.05-2.00) were associated with increased risk in those ≥60 years.</p><p><strong>Conclusions: </strong>BMI change was associated with cervical and ovarian cancer risk, with direction and magnitude varying by age.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147776026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Estriol suppositories enhance colposcopy sufficiency and diagnostic accuracy in postmenopausal women: a comparative study. 雌三醇栓剂提高绝经后妇女阴道镜检查的充分性和诊断准确性:一项比较研究。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-04-21 DOI: 10.1097/GME.0000000000002801
Fenghe Li, Yongjing Zhang, Xiaorui Yuan, Tianqi Han, Lei Wang, Xiaomeng Xia
{"title":"Estriol suppositories enhance colposcopy sufficiency and diagnostic accuracy in postmenopausal women: a comparative study.","authors":"Fenghe Li, Yongjing Zhang, Xiaorui Yuan, Tianqi Han, Lei Wang, Xiaomeng Xia","doi":"10.1097/GME.0000000000002801","DOIUrl":"https://doi.org/10.1097/GME.0000000000002801","url":null,"abstract":"<p><strong>Objectives: </strong>Postmenopausal estrogen deficiency leads to atrophy of the urogenital tract and atrophic vaginitis, which can impact the results of colposcopy. This study evaluated the benefits of estriol suppositories on colposcopy sufficiency, diagnostic accuracy, and patient comfort in postmenopausal women.</p><p><strong>Methods: </strong>A prospective intervention group of 95 postmenopausal women was enrolled. All participants received 0.5 mg estriol suppositories for 20 days before colposcopy. This prospective intervention group was compared with a historical control group of 101 women who had received other medications. Outcomes, including colposcopy sufficiency, visibility of the squamocolumnar junction (SCJ) and transformation zone (TZ), diagnostic agreement rate between colposcopy diagnosis and histopathology, and pain degrees, were assessed. The diagnostic agreement rate between colposcopic diagnosis and pathological diagnosis was analyzed using Kappa analysis.</p><p><strong>Results: </strong>Within the prospective intervention group, colposcopy sufficiency was significantly improved after pretreatment (χ 2 =85.011, P <0.001). However, no significant change was found in visibility of the SCJ (2.11% vs. 4.21%, P =0.683) and TZ types (χ 2 =0.167, P =0.683). The weighted kappa was 0.584 ( P <0.001), indicating a moderate degree of consistency. Pain degrees were significantly reduced after pretreatment ( P <0.001). 10.53% of participants experienced adverse events. After propensity score matching (n=58 per group), the prospective intervention group demonstrated a significantly higher sufficiency compared with the historical control group (94.83% vs. 67.24%, χ 2 =14.360, P <0.001). There were no statistically significant differences in SCJ visibility or TZ type between the two groups (both P >0.05). The weighted kappa between the two groups was 0.001 ( P =0.011), indicating an extremely low degree of consistency.</p><p><strong>Conclusions: </strong>Pretreatment with estriol suppositories significantly improves colposcopy sufficiency, enhances diagnostic agreement rate with histopathology, and alleviates procedure-related pain in postmenopausal women, while maintaining an acceptable safety profile.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147775991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Food and Drug Administration boxed warning on menopausal hormone therapy: history, impact, and a regulatory inflection point in women's health. 美国食品和药物管理局关于绝经期激素治疗的黑框警告:历史、影响和妇女健康的监管拐点。
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-04-14 DOI: 10.1097/GME.0000000000002793
Laura A Buchanan, Matthew W Calkins, Julienne K Kirk
{"title":"The Food and Drug Administration boxed warning on menopausal hormone therapy: history, impact, and a regulatory inflection point in women's health.","authors":"Laura A Buchanan, Matthew W Calkins, Julienne K Kirk","doi":"10.1097/GME.0000000000002793","DOIUrl":"https://doi.org/10.1097/GME.0000000000002793","url":null,"abstract":"<p><p>The removal of the Food and Drug Administration boxed warning from menopausal hormone therapy (MHT) products in November 2025 marks a historic regulatory inflection point in women's health. This manuscript reviews the history and purpose of boxed warnings, examines the Women's Health Initiative-era rationale that led to the class-wide application of boxed warnings across all MHT formulations and routes of administration, and analyzes the long-term clinical, educational, and public health consequences of MHT avoidance driven largely by this regulatory action. We synthesize decades of post Women's Health Initiative evidence demonstrating substantial heterogeneity in MHT risk and benefit by age, timing of initiation, formulation, and route of administration. To contextualize the lifecycle of the MHT boxed warning, we compare it with three instructive regulatory parallels: canagliflozin, illustrating regulatory agility when benefit- risk balance evolves; varenicline, showing how a boxed warning led to a sharp decline in prescribing that was later not supported by randomized trial evidence; and topical calcineurin inhibitors, highlighting the pitfalls of route-agnostic class-effect labeling. We further examine the persistent impact of the boxed warning on prescribing patterns, menopause education, and primary care training, and propose a framework for regulatory reform and necessary clinician education.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147675005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial. GS1-144(一种新型神经激肽3受体拮抗剂)治疗中国女性更年期相关中重度血管舒缩症状的有效性和安全性:一项随机、双盲、安慰剂对照的2期试验
IF 3 3区 医学
Menopause: The Journal of The North American Menopause Society Pub Date : 2026-04-14 DOI: 10.1097/GME.0000000000002748
Yaping Wang, Xuefeng Wang, Wei Wang, Jiajing Lin, Yao He, Hua Chen, Huafeng Shou, Xiaoyan Ai, Qinghua Zhang, Yiling Cai, Yinglan Wu, Ruixia Guo, Lina Hu, Haijun Chen, Wei Xiang, Chao Pan, Qi Yu
{"title":"Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial.","authors":"Yaping Wang, Xuefeng Wang, Wei Wang, Jiajing Lin, Yao He, Hua Chen, Huafeng Shou, Xiaoyan Ai, Qinghua Zhang, Yiling Cai, Yinglan Wu, Ruixia Guo, Lina Hu, Haijun Chen, Wei Xiang, Chao Pan, Qi Yu","doi":"10.1097/GME.0000000000002748","DOIUrl":"https://doi.org/10.1097/GME.0000000000002748","url":null,"abstract":"<p><strong>Objective: </strong>This multicenter, randomised, double-blind, placebo-controlled, phase 2 trial investigated the efficacy and safety of the selective neurokinin 3 receptor (NK3R) antagonist GS1-144 for moderate-to-severe vasomotor symptoms (VMS).</p><p><strong>Methods: </strong>Eligible participants aged between 40 and 64 years randomly (1:1:1:1) received GS1-144 30 mg once daily (QD), 60 mg QD, or 30 mg twice daily (BID) and placebo for 12 weeks. Co-primary endpoints were the mean change in the frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12.</p><p><strong>Results: </strong>Among 276 randomized participants, 271 (98.2%) and 258 (93.5%) completed 4 and 12 weeks of treatment, respectively. VMS frequency was significantly reduced versus placebo for GS1-144 30 mg BID at week 4 (difference in change in least squares mean -1.31 [90% CI: -2.35 to -0.26], P=0.04) and week 12 (-1.41 [-2.28 to -0.54], P=0.008), and for GS1-144 60 mg QD at week 12 (-1.42 [-2.28 to 0.55], P=0.007). GS1-144 30 mg BID and 60 mg QD significantly reduced VMS severity versus placebo at week 4 (-0.14 [-0.26 to -0.01], P=0.07; -0.13 [-0.26 to -0.01], P=0.07) and week 12 (-0.24 [-0.43 to -0.05], P=0.04; -0.19 [-0.38 to 0.00], P=0.098). Treatment-emergent adverse events occurred in 67.6% (140/207) of participants who received GS1-144 and 62.3% (43/69) in the placebo group. No liver safety risks were observed with GS1-144.</p><p><strong>Conclusions: </strong>GS1-144 is well tolerated and significantly reduces VMS frequency and severity in postmenopausal Chinese women.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147675001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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