This application describes one of five proposals being submitted in conjunction with the network application entitled, """"""""The Menopausal Symptoms Initiative -Finding Lasting Answers to Sweats and Hot Flashes (MSI- FLASH)"""""""". Our network and data coordinating center (DCC) will be jointly led by two Co-PIs of the Women's Health Initiative, Clinical Coordinating Center (Seattle) who have worked together for over a decade (LaCroix, Anderson, PIs). The MSI-FLASH network has five clinical sites: Boston, MA (Cohen, Joffe, PIs);Indianapolis, IN (Carpenter, PI);Oakland, CA (Sternfeld, Caan, PIs);Philadelphia, PA (Freeman, PI);and Seattle, WA (Newton, Reed, PIs). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions. Our overall goal is to fulfill the main objective of the RFA, """"""""New Interventions for Menopausal Symptoms (U01)"""""""", to accelerate the identification of effective remedies for vasomotor symptoms (VMS). In this site application we propose a multicenter, factorial design, RCT of yoga, ultra low-dose estradiol (E2) gel and placebo gel to be conducted in Seattle, Indianapolis and Boston. The primary aims are to: 1. Evaluate the effects of yoga vs. no yoga on: a) subjective VMS frequency;and b) VMS bothersomeness;and 2. Evaluate the effects of ultra-low dose estrogen (E2) gel vs. placebo gel on: a) subjective VMS frequency;and b) bothersomeness. Our hypotheses are that 1. The effect of yoga will be greater than no yoga on: a) subjective VMS frequency and b) VMS bothersomeness;and 2. The effect of ultra-low dose E2 gel will be greater than no E2 gel on: a) subjective VMS frequency;and b) bothersomeness. Our secondary aims are: 1. To evaluate the effects of yoga and ultra-low dose E2 gel on other common menopause outcomes including: a) objective VMS frequency (Bahr monitor);b) sleep (PSQI, Actigraph"""""""");and c) mood (CESD, HADS);and 2. To examine whether the combined effect of yoga and ultra low-dose E2 on our primary and secondary outcomes is greater than the effect of either alone. To accomplish our specific aims we will: 1) recruit and randomize 400 women to one of 4 treatment arms for 12 weeks (placebo gel;yoga + placebo gel;ultra low-dose E2 gel;yoga + ultra low-dose E2 gel);2) measure primary and secondary outcomes at baseline and 12 weeks;and 3) compare changes in outcomes in yoga and ultra low-dose E2 gel groups to placebo;and 4) compare changes in primary and secondary outcomes for yoga + ultra low-dose E2 gel to the effects of either intervention alone (if yoga alone is efficacious).

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG032682-05
Application #
8312527
Study Section
Special Emphasis Panel (ZAG1-ZIJ-5 (M2))
Program Officer
Hannah, Judy S
Project Start
2008-09-15
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2012
Total Cost
$275,158
Indirect Cost
$110,009
Name
Group Health Cooperative
Department
Type
DUNS #
078198520
City
Seattle
State
WA
Country
United States
Zip Code
98101
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
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
Freeman, Ellen W; Ensrud, Kristine E; Larson, Joseph C et al. (2015) Placebo improvement in pharmacologic treatment of menopausal hot flashes: time course, duration, and predictors. Psychosom Med 77:167-75
Carpenter, J S; Woods, N F; Otte, J L et al. (2015) MsFLASH participants' priorities for alleviating menopausal symptoms. Climacteric 18:859-66

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