MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
NCT ID: NCT00894543
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
205 participants
INTERVENTIONAL
2009-07-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Escitalopram
Escitalopram is a selective serotonin reuptake inhibitor (SSRI)
Escitalopram
10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.
Placebo
Inactive pill
Placebo
Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.
Interventions
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Escitalopram
10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.
Placebo
Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Menopausal, including:
* Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval ≥60 days in the past 12 months.
* Women who have had a bi-lateral oophorectomy (surgical removal of both ovaries).
* Women without a uterus who still have ovaries, under certain conditions determined during screening.
* Having bothersome hot flashes.
* In general good health as determined by medical history and physical measures.
* Signed informed consent.
Exclusion Criteria
* Use of any other therapy that is taken specifically for hot flashes, including prescription, over-the-counter, or herbal therapies in the past month and duration of the study.
* Any current severe or unstable medical illness.
* Uncontrolled hypertension (\>160/100) or resting heart rate \>110.
* History of endometrial or ovarian cancer; MI, angina, or cerebrovascular events.
* Pregnancy, intending pregnancy, breast feeding.
* Current participation in another drug trial or intervention study.
* Inability or unwillingness to complete the study procedures.
* Certain other conditions, determined during screening.
* Use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors during the two months before enrollment.
* Use of gabapentin, pregabalin, triptans, warfarin (Coumadin®), or St. John's Wort.
* Known hypersensitivity to escitalopram (Lexapro®) or citalopram (Celexa®).
* Use of antidepressants during the past 30 days before starting Study 01, including SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and anxiolytics.
* Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period.
* History of liver, gall bladder, renal disease, or uncontrolled seizure disorder.
* Certain other conditions, determined during screening.
40 Years
62 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Research on Women's Health (ORWH)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Ellen W Freeman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Medical Center
Andrea Z LaCroix, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Garnet L Anderson, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Kris Ensrud, MD
Role: STUDY_CHAIR
University of Minnesota
Locations
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Northern California Kaiser, Division of Research
Oakland, California, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital, Harvard Medical School
Boston, Massachusetts, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Freeman EW, Guthrie KA, Caan B, Sternfeld B, Cohen LS, Joffe H, Carpenter JS, Anderson GL, Larson JC, Ensrud KE, Reed SD, Newton KM, Sherman S, Sammel MD, LaCroix AZ. Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA. 2011 Jan 19;305(3):267-74. doi: 10.1001/jama.2010.2016.
Carpenter JS, Guthrie KA, Larson JC, Freeman EW, Joffe H, Reed SD, Ensrud KE, LaCroix AZ. Effect of escitalopram on hot flash interference: a randomized, controlled trial. Fertil Steril. 2012 Jun;97(6):1399-404.e1. doi: 10.1016/j.fertnstert.2012.03.001. Epub 2012 Apr 3.
Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55. doi: 10.1097/gme.0b013e3182476099.
Reed SD, Guthrie KA, Joffe H, Shifren JL, Seguin RA, Freeman EW. Sexual function in nondepressed women using escitalopram for vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Mar;119(3):527-38. doi: 10.1097/AOG.0b013e3182475fa4.
LaCroix AZ, Freeman EW, Larson J, Carpenter JS, Joffe H, Reed SD, Newton KM, Seguin RA, Sternfeld B, Cohen L, Ensrud KE. Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: a randomized controlled trial. Maturitas. 2012 Dec;73(4):361-8. doi: 10.1016/j.maturitas.2012.09.006. Epub 2012 Sep 30.
Joffe H, Guthrie KA, Larson J, Cohen LS, Carpenter JS, Lacroix AZ, Freeman EW. Relapse of vasomotor symptoms after discontinuation of the selective serotonin reuptake inhibitor escitalopram: results from the menopause strategies: finding lasting answers for symptoms and health research network. Menopause. 2013 Mar;20(3):261-8. doi: 10.1097/GME.0b013e31826d3108.
Diem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
Guthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
Guthrie KA, LaCroix AZ, Ensrud KE, Joffe H, Newton KM, Reed SD, Caan B, Carpenter JS, Cohen LS, Freeman EW, Larson JC, Manson JE, Rexrode K, Skaar TC, Sternfeld B, Anderson GL. Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms. Obstet Gynecol. 2015 Aug;126(2):413-422. doi: 10.1097/AOG.0000000000000927.
Newton KM, Carpenter JS, Guthrie KA, Anderson GL, Caan B, Cohen LS, Ensrud KE, Freeman EW, Joffe H, Sternfeld B, Reed SD, Sherman S, Sammel MD, Kroenke K, Larson JC, Lacroix AZ. Methods for the design of vasomotor symptom trials: the menopausal strategies: finding lasting answers to symptoms and health network. Menopause. 2014 Jan;21(1):45-58. doi: 10.1097/GME.0b013e31829337a4.
Other Identifiers
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