The long-term objective of NIA's RFA-AG-08-004 entitled, """"""""New Interventions for Menopausal Symptoms (U01) is to accelerate progress in identifying effective remedies for vasomotor symptoms (VMS) in women going through the menopausal transition. 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 mission. This Data Coordinating Center (DCC) application is being submitted in conjunction with the network entitled, """"""""The Menopausal Symptoms Initiative-Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)"""""""". Our DCC will be jointly led by Andrea LaCroix and Garnet Anderson who have served together as Co-Principal Investigators of the Women's Health Initiative Clinical Coordinating Center (Seattle) for more than a decade. The MSI-FLASH network has five clinical sites located in Boston (Lee Cohen and Hadine Joffe, PIs), Indianapolis, IN (Janet Carpenter, PI), Oakland, CA (Barbara Sternfeld and Bette Caan, PIs), Philadelphia (Ellen Freeman, PI) and Seattle (Katherine Newton and Susan Reed, PIs). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions to treat hot flashes. The specific objectives of the DCC are to: 1) Provide and coordinate all necessary leadership activities to facilitate collaboration and productivity among network scientists during all phases in the lifecycle of VMS clinical trials from hypothesis formulation to publication, dissemination, and data sharing;2) Build upon 15 years of experience and well established human and operational resources to coordinate 5 or more multi- site randomized trials including support of protocol development, recruitment, intervention, data collection and management, and statistical analysis;and 3) Create the infrastructure to involve an expanded network of scientists from the US and worldwide to facilitate the development and use of common methodologies and measurements for VMS trials inside and outside of this trial network so that emerging new treatments for hot flashes can be rapidly identified and rigorously tested for efficacy and safety with comparable results.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG032699-04
Application #
8143386
Study Section
Special Emphasis Panel (ZAG1-ZIJ-5 (M2))
Program Officer
Hannah, Judy S
Project Start
2008-09-15
Project End
2013-08-31
Budget Start
2011-09-01
Budget End
2012-08-31
Support Year
4
Fiscal Year
2011
Total Cost
$2,577,565
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Mitchell, Caroline M; Srinivasan, Sujatha; Zhan, Xiang et al. (2017) Vaginal microbiota and genitourinary menopausal symptoms: a cross-sectional analysis. Menopause 24:1160-1166
Mitchell, Caroline M; Srinivasan, Sujatha; Plantinga, Anna et al. (2017) Associations between improvement in genitourinary symptoms of menopause and changes in the vaginal ecosystem. Menopause :
Woods, Nancy Fugate; Hohensee, Chancellor; Carpenter, Janet S et al. (2016) Symptom clusters among MsFLASH clinical trial participants. Menopause 23:158-65
Jones, Salene M W; Guthrie, Katherine A; Reed, Susan D et al. (2016) A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability. Complement Ther Med 26:66-71
Carpenter, Janet S; Jones, Salene M W; Studts, Christina R et al. (2016) Female Sexual Function Index Short Version: A MsFLASH Item Response Analysis. Arch Sex Behav 45:1897-1905
Jones, Salene M W; Guthrie, Katherine A; LaCroix, Andrea Z et al. (2016) Is heart rate variability associated with frequency and intensity of vasomotor symptoms among healthy perimenopausal and postmenopausal women? Clin Auton Res 26:7-13
Reed, S D; Newton, K M; Larson, J C et al. (2016) Daily salivary cortisol patterns in midlife women with hot flashes. Clin Endocrinol (Oxf) 84:672-9
McCurry, Susan M; Guthrie, Katherine A; Morin, Charles M et al. (2016) Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial. JAMA Intern Med 176:913-20
Oakley, Amy E; Steiner, Robert A; Chavkin, Charles et al. (2015) ? Agonists as a novel therapy for menopausal hot flashes. Menopause 22:1328-34
Caan, Bette; LaCroix, Andrea Z; Joffe, Hadine et al. (2015) Effects of estrogen and venlafaxine on menopause-related quality of life in healthy postmenopausal women with hot flashes: a placebo-controlled randomized trial. Menopause 22:607-15

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