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
Diem, Susan J; Joffe, Hadine; Larson, Joseph C et al. (2014) Effects of escitalopram on markers of bone turnover: a randomized clinical trial. J Clin Endocrinol Metab 99:E1732-7
Joffe, Hadine; Guthrie, Katherine A; LaCroix, Andrea Z et al. (2014) Low-dose estradiol and the serotonin-norepinephrine reuptake inhibitor venlafaxine for vasomotor symptoms: a randomized clinical trial. JAMA Intern Med 174:1058-66
Newton, Katherine M; Carpenter, Janet S; Guthrie, Katherine A et al. (2014) Methods for the design of vasomotor symptom trials: the menopausal strategies: finding lasting answers to symptoms and health network. Menopause 21:45-58
Reed, Susan D; Mitchell, Caroline M; Joffe, Hadine et al. (2014) Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. Obstet Gynecol 124:233-41
Newton, Katherine M; Reed, Susan D; Guthrie, Katherine A et al. (2014) Efficacy of yoga for vasomotor symptoms: a randomized controlled trial. Menopause 21:339-46
Reed, Susan D; Guthrie, Katherine A; Newton, Katherine M et al. (2014) Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements. Am J Obstet Gynecol 210:244.e1-11
Sternfeld, Barbara; LaCroix, Andrea; Caan, Bette J et al. (2013) Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: the MsFLASH experience. Contemp Clin Trials 35:25-34
Carpenter, Janet S; Newton, Katherine M; Sternfeld, Barbara et al. (2012) Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network. Menopause 19:664-71
Reed, Susan D; Guthrie, Katherine A; Joffe, Hadine et al. (2012) Sexual function in nondepressed women using escitalopram for vasomotor symptoms: a randomized controlled trial. Obstet Gynecol 119:527-38
Carpenter, Janet S; Guthrie, Katherine A; Larson, Joseph C et al. (2012) Effect of escitalopram on hot flash interference: a randomized, controlled trial. Fertil Steril 97:1399-404.e1

Showing the most recent 10 out of 11 publications