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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG032700-05
Application #
8312525
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
$295,729
Indirect Cost
$180,316
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199
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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
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
Carpenter, J S; Woods, N F; Otte, J L et al. (2015) MsFLASH participants' priorities for alleviating menopausal symptoms. Climacteric 18:859-66
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
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
Otte, Julie L; Rand, Kevin L; Landis, Carol A et al. (2015) Confirmatory factor analysis of the Pittsburgh Sleep Quality Index in women with hot flashes. Menopause 22:1190-6
Guthrie, Katherine A; LaCroix, Andrea Z; Ensrud, Kristine E et al. (2015) Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms. Obstet Gynecol 126:413-22
Ensrud, Kristine E; Guthrie, Katherine A; Hohensee, Chancellor et al. (2015) Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes. Sleep 38:97-108

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