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.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZAG1-ZIJ-5 (M2))
Program Officer
Hannah, Judy S
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Massachusetts General Hospital
United States
Zip Code
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

Showing the most recent 10 out of 29 publications