干旱区生态环境知识资源中心(Arid): Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause

Arid

DOI	10.1097/GME.0000000000002350
	Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause
	Pinkerton, JoAnn V.; Simon, James; Panay, Nick; Seitz, Christian; Parke, Susanne; Caetano, Cecilia; Mellinger, Uwe; Mashhadi, Nazanin Haseli; Haberland, Claudia; Atanackovic, Gordana; Holz, Cornelia; Mao, Guangping; Morrison, Marina; Nisius, Sven; Schaefers, Matthias; Zuurman, Lineke
通讯作者	Pinkerton, JV
来源期刊	MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY
ISSN	1072-3714
EISSN	1530-0374
出版年	2024
卷号	31 期号:6 页码:522-529
英文摘要	The OASIS 1 and 2 pivotal Phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for vasomotor symptoms, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. ObjectiveElinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS.MethodsThe OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance. Postmenopausal women with moderate/severe VMS are randomized to receive 120 mg elinzanetant or placebo once daily for 12 weeks, followed by a 14-week active treatment extension. Primary endpoints are the mean change in frequency and severity of moderate/severe VMS from baseline to weeks 4 and 12. Key secondary endpoints will assess the onset of action and effects on sleep disturbance and menopause-related quality of life. Primary and key secondary endpoints will be analyzed using a mixed model with repeated measures. Feedback from postmenopausal women with VMS was used during protocol development.ResultsWomen confirmed the relevance of endpoints that assess the impact of VMS, sleep disturbance, and mood changes, and the need for new nonhormone treatments. Educational materials around study design, conduct and expected assessments and procedures were developed based on questions and concerns raised by women.ConclusionsThe OASIS 1 and 2 pivotal phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for VMS, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials.
英文关键词	Elinzanetant Hot flashes Menopause Neurokinin-1 Neurokinin-3 Patient feedback Vasomotor symptoms
类型	Article
语种	英语
开放获取类型	hybrid
收录类别	SCI-E
WOS记录号	WOS:001230494400009
WOS关键词	QUALITY-OF-LIFE ; ANTAGONIST GSK1144814 ; DOUBLE-BLIND ; SLEEP ; QUESTIONNAIRE
WOS类目	Obstetrics & Gynecology
WOS研究方向	Obstetrics & Gynecology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/404902
推荐引用方式 GB/T 7714	Pinkerton, JoAnn V.,Simon, James,Panay, Nick,et al. Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause[J],2024,31(6):522-529.
APA	Pinkerton, JoAnn V..,Simon, James.,Panay, Nick.,Seitz, Christian.,Parke, Susanne.,...&Zuurman, Lineke.(2024).Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause.MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY,31(6),522-529.
MLA	Pinkerton, JoAnn V.,et al."Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause".MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY 31.6(2024):522-529.