MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMS

MSI-FLASH：激素和非激素干预对 VMS 的相对疗效

• 批准号: 7682067
• 负责人: LEE S COHEN
• 金额: $ 31.44万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7682067
• 关键词: Adverse event; Antidepressive Agents; Anxiety; Behavior Therapy; Behavioral; Boston; Characteristics; Clinical; Clinical Trials; Clinical Trials Network; Complex; Consultations; Data; Data Coordinating Center; Dose; Estrogen Therapy; Estrogens; FDA approved; Goals; Head; High Prevalence; Hormonal; Hot flushes; Intervention; Lead; Measurement; Measures; Menopausal Symptom; Menopause; Multi-Institutional Clinical Trial; Nature; Paroxetine; Pattern; Perimenopause; Philadelphia; Placebos; Positioning Attribute; Postmenopause; Principal Investigator; Public Health; Randomized; Randomized Controlled Trials; Relative (related person); Research Personnel; Scientist; Selective Serotonin Reuptake Inhibitor; Site; Sleep; Sleep disturbances; Sweat; Sweating; Symptoms; Testing; Woman; Women' s Health; clinical research site; comparative efficacy; depression; double-blind placebo controlled trial; effective therapy; experience; hormone therapy; improved; multidisciplinary; programs; response; treatment strategy

DESCRIPTION (provided by applicant): The main objective of this network application, as established by the RFA-New Interventions for Menopausal Symptoms (UO1)-is to accelerate the identification of effective remedies to relieve hot flashes. We have created a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials to fulfill this objective: "The Menopausal Symptoms Initiative-Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)." Our Data Coordinating Center will be led jointly by Andrea LaCroix and Garnet Anderson who have served together as Co-Principal Investigators of the Women's Health Initiative Clinical Coordinating Center for over a decade. The MSI- FLASH network has five clinical sites: Boston (PIs: Lee Cohen and Hadine Joffe), Indianapolis (PI: Janet Carpenter), Oakland (PIs: Barbara Sternfeld and Bette Caan), Philadelphia (PI: Ellen Freeman) and Seattle (PIs: Katherine Newton and Susan Reed). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, hormonal and non-hormonal pharmacologic interventions to treat hot flashes. The specific trial proposed by our Boston site will test the relative efficacy of low-dose estrogen therapy and the selective serotonin-reuptake inhibitor (SSRI) paroxetine for the treatment of hot flashes. This randomized placebo-controlled double-blind trial includes: 1) a "head-to-head" comparison of the efficacy of estrogen and paroxetine; 2) a comparison of each intervention with placebo; 3) an assessment of potential modulating effects of co-occurring menopausal symptoms of sleep disturbance, depression, and anxiety; and 4) an examination of the complex inter-relationships between hot flashes and other menopausal symptoms using both subjective and objective measurements of hot flashes and sleep patterns. The Boston clinical site investigators have extensive experience with both hormonal and non-hormonal pharmacologic trials, as well as with behavioral interventions, and are well-positioned to collaborate on trials proposed by other MSI-FLASH clinical site investigators. Results of our proposed clinical trial will advance the treatment of hot flashes by establishing the relative efficacy of first-line pharmacologic treatments and determining whether specific clinical characteristics modulate response to treatment.

描述（由申请人提供）：根据RFA-月经症状新干预措施（UO 1）的规定，该网络申请的主要目的是加速确定缓解潮热的有效补救措施。我们建立了一个科学家网络，他们对更年期过渡非常了解，并在进行女性健康试验方面经验丰富，以实现这一目标：“月经症状倡议-寻找出汗和潮热的持久答案（MSI-FLASH）。“我们的数据协调中心将由Andrea LaCroix和Garnet安德森共同领导，他们曾共同担任妇女健康倡议临床协调中心的联合主要研究员超过十年。MSI- FLASH网络有五个临床站点：波士顿（PI：Lee Cohen和Hadine Joffe）、印第安纳波利斯（PI：Janet Carpenter）、奥克兰（PI：Barbara Sternfeld和Bette Caan）、费城（PI：Ellen Freeman）和西雅图（PI：凯瑟琳牛顿和苏珊里德）。这个多学科研究小组提出了五项随机对照试验，测试一系列治疗潮热的行为、激素和非激素药物干预措施。我们波士顿研究中心提出的具体试验将测试低剂量雌激素治疗和选择性降钙素再摄取抑制剂（SSRI）帕罗西汀治疗潮热的相对疗效。这项随机安慰剂对照的双盲试验包括：1）雌激素和帕罗西汀疗效的“头对头”比较; 2）每种干预与安慰剂的比较; 3）对同时发生的睡眠障碍、抑郁和焦虑的更年期症状的潜在调节作用的评估;和4）使用潮热和睡眠模式的主观和客观测量来检查潮热和其它绝经期症状之间的复杂相互关系。波士顿临床研究中心的研究者在激素和非激素药理学试验以及行为干预方面都有丰富的经验，并且能够很好地与其他MSI-FLASH临床研究中心的研究者合作。我们提出的临床试验的结果将通过建立一线药物治疗的相对疗效和确定特定的临床特征是否调节对治疗的反应来促进潮热的治疗。