{"protocolSection":{"identificationModule":{"nctId":"NCT00894543","orgStudyIdInfo":{"id":"MsFLASH-01"},"secondaryIdInfos":[{"id":"1U01AG032699-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1U01AG032699-01"},{"id":"1U01AG032656-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1U01AG032656-01"}],"organization":{"fullName":"Fred Hutchinson Cancer Center","class":"OTHER"},"briefTitle":"MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women","officialTitle":"Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women"},"statusModule":{"statusVerifiedDate":"2013-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-07"},"primaryCompletionDateStruct":{"date":"2010-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2009-05-05","studyFirstSubmitQcDate":"2009-05-05","studyFirstPostDateStruct":{"date":"2009-05-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-02-17","resultsFirstSubmitQcDate":"2011-03-21","resultsFirstPostDateStruct":{"date":"2011-03-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-03-05","lastUpdatePostDateStruct":{"date":"2013-03-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Andrea LaCroix, Garnet Anderson","oldOrganization":"Fred Hutchinson Cancer Research Center"},"leadSponsor":{"name":"Fred Hutchinson Cancer Center","class":"OTHER"},"collaborators":[{"name":"National Institute on Aging (NIA)","class":"NIH"},{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","class":"NIH"},{"name":"National Center for Complementary and Integrative Health (NCCIH)","class":"NIH"},{"name":"Office of Research on Women's Health (ORWH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to test whether a medication reduces the number, severity and bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot flashes. This research study will test whether escitalopram reduces menopausal hot flashes.","detailedDescription":"The MsFLASH-01 study, Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women is a randomized, double-blind, placebo-controlled, parallel arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes prior to drug treatment; 8 weeks of double-blind treatment with escitalopram or placebo with dose escalation at 4 weeks among non-responders; 1 week of drug taper for those on higher dose, followed by 2 weeks with no treatment; and a telephone follow-up post-treatment. This study is one of five clinical trials to be conducted as part of the Menopause Strategies - Finding Lasting Answers for Symptoms and Health (MsFLASH) study, a network of investigators and clinical trials designed to find new ways to alleviate the most common, bothersome symptoms of the menopausal transition."},"conditionsModule":{"conditions":["Hot Flashes","Menopause","Vasomotor Symptoms"],"keywords":["Hot flashes","Menopause","Vasomotor symptoms"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":205,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"ACTIVE_COMPARATOR","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI)","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Inactive pill","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"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.","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro®."]},{"type":"OTHER","name":"Placebo","description":"Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries","description":"Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.","timeFrame":"Baseline"},{"measure":"Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.","timeFrame":"week 4 minus baseline"},{"measure":"Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.","timeFrame":"week 8 minus baseline"},{"measure":"Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries","description":"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.\n\nHot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"Baseline"},{"measure":"Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.\n\nHot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"week 4 minus baseline"},{"measure":"Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash severity between baseline \\& week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"week 8 minus baseline"}],"secondaryOutcomes":[{"measure":"Daily Hot Flash Bother, Recorded on Daily Diaries","description":"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.\n\nHot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"Baseline"},{"measure":"Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries","description":"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.\n\nHot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"week 4 minus baseline"},{"measure":"Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries","description":"Change in daily hot flash bother between baseline \\& week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","timeFrame":"week 8 minus baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria, Common to all MsFLASH Studies:\n\n* Females aged 40-62 years.\n* Menopausal, including:\n\n  * Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval ≥60 days in the past 12 months.\n  * Women who have had a bi-lateral oophorectomy (surgical removal of both ovaries).\n  * Women without a uterus who still have ovaries, under certain conditions determined during screening.\n* Having bothersome hot flashes.\n* In general good health as determined by medical history and physical measures.\n* Signed informed consent.\n\nExclusion Criteria, Common to all MsFLASH Studies:\n\n* Use of hormone therapy or hormonal contraceptives during the 2 months before enrollment and for the duration of the study. Certain exceptions apply, determined during screening.\n* 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.\n* Any current severe or unstable medical illness.\n* Uncontrolled hypertension (\\>160/100) or resting heart rate \\>110.\n* History of endometrial or ovarian cancer; MI, angina, or cerebrovascular events.\n* Pregnancy, intending pregnancy, breast feeding.\n* Current participation in another drug trial or intervention study.\n* Inability or unwillingness to complete the study procedures.\n* Certain other conditions, determined during screening.\n\nExclusion Criteria, Specific to MsFLASH-01:\n\n* Use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors during the two months before enrollment.\n* Use of gabapentin, pregabalin, triptans, warfarin (Coumadin®), or St. John's Wort.\n* Known hypersensitivity to escitalopram (Lexapro®) or citalopram (Celexa®).\n* 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.\n* Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period.\n* History of liver, gall bladder, renal disease, or uncontrolled seizure disorder.\n* Certain other conditions, determined during screening.","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"40 Years","maximumAge":"62 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ellen W Freeman, PhD","affiliation":"University of Pennsylvania Medical Center","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Andrea Z LaCroix, PhD","affiliation":"Fred Hutchinson Cancer Center","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Garnet L Anderson, PhD","affiliation":"Fred Hutchinson Cancer Center","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Kris Ensrud, MD","affiliation":"University of Minnesota","role":"STUDY_CHAIR"}],"locations":[{"facility":"Northern California Kaiser, Division of Research","city":"Oakland","state":"California","zip":"94612","country":"United States","geoPoint":{"lat":37.80437,"lon":-122.2708}},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Massachusetts General Hospital, Harvard Medical School","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Brigham and Women's Hospital","city":"Chestnut Hill","state":"Massachusetts","zip":"02467","country":"United States","geoPoint":{"lat":42.33065,"lon":-71.16616}},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}}]},"referencesModule":{"references":[{"pmid":"21245182","type":"RESULT","citation":"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."},{"pmid":"22480818","type":"RESULT","citation":"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."},{"pmid":"22433978","type":"RESULT","citation":"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."},{"pmid":"22353950","type":"RESULT","citation":"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."},{"pmid":"23031421","type":"RESULT","citation":"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."},{"pmid":"23435022","type":"RESULT","citation":"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."},{"pmid":"32701665","type":"DERIVED","citation":"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."},{"pmid":"29165623","type":"DERIVED","citation":"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."},{"pmid":"26241433","type":"DERIVED","citation":"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."},{"pmid":"23760428","type":"DERIVED","citation":"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Following enrollment (signing the consent), symptoms and health were reviewed, brief physical exam conducted and urine pregnancy test administered, daily hot flash diaries completed for one week (in addition to two weeks before enrollment).","recruitmentDetails":"Participants were recruited from July 2009 to June 2010. The trial was conducted at four MsFLASH network sites: University of Pennsylvania, Massachusetts General Hospital, Indiana University, Kaiser Permanente Division of Research in Oakland, California","groups":[{"id":"FG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"FG001","title":"Placebo","description":"Inactive pill"}],"periods":[{"title":"Baseline","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"101"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"101"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Baseline to Week 4","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"101"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"99"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"No diary or lost or withdrew","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}]},{"title":"Week 4 to Week 8","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"99"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"97"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"No diary or lost or withdrew","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"BG001","title":"Placebo","description":"Inactive pill"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"101"},{"groupId":"BG002","value":"205"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"101"},{"groupId":"BG002","value":"205"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.45","spread":"4.20"},{"groupId":"BG001","value":"54.36","spread":"3.86"},{"groupId":"BG002","value":"53.9","spread":"4.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"101"},{"groupId":"BG002","value":"205"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"95"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"102"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"101"},{"groupId":"BG002","value":"205"}]}]}]},{"title":"Menopausal Status","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Postmenopause","categories":[{"measurements":[{"groupId":"BG000","value":"84"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"167"}]}]},{"title":"Late transition","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"32"}]}]},{"title":"Early transition","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Body Mass Index (BMI)","description":"BMI calculated as (body weight in kilograms) divided by (body height in meters squared) (kg/m\\^2)","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"<25, kg/m^2","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"54"}]}]},{"title":"25-<30, kg/m^2","categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"72"}]}]},{"title":">=30, kg/m^2","categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"78"}]}]},{"title":"Missing data","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Hysterectomy","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Hysterectomy","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"26"}]}]},{"title":"Hysterectomy and oophorectomy","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"19"}]}]},{"title":"Oophorectomy only","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}]},{"title":"None","categories":[{"measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"155"}]}]},{"title":"Don't know","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries","description":"Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Hot flashes/day","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.88","lowerLimit":"8.67","upperLimit":"11.10"},{"groupId":"OG001","value":"9.66","lowerLimit":"8.70","upperLimit":"10.63"}]}]}]},{"type":"SECONDARY","title":"Daily Hot Flash Bother, Recorded on Daily Diaries","description":"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.\n\nHot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.12","lowerLimit":"3.03","upperLimit":"3.22"},{"groupId":"OG001","value":"3.16","lowerLimit":"3.06","upperLimit":"3.26"}]}]}]},{"type":"PRIMARY","title":"Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Hot flashes/day","timeFrame":"week 4 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"99"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.37","lowerLimit":"-5.24","upperLimit":"-3.50"},{"groupId":"OG001","value":"-2.49","lowerLimit":"-3.31","upperLimit":"-1.66"}]}]}]},{"type":"PRIMARY","title":"Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Hot flashes/day","timeFrame":"week 8 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.60","lowerLimit":"-5.47","upperLimit":"-3.74"},{"groupId":"OG001","value":"-3.20","lowerLimit":"-4.15","upperLimit":"-2.24"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).","statisticalMethod":"Regression, Linear","statisticalComment":"Natural log transformations applied to hot flash frequencies for modeling assumptions."}]},{"type":"PRIMARY","title":"Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries","description":"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.\n\nHot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"101"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.16","lowerLimit":"2.07","upperLimit":"2.24"},{"groupId":"OG001","value":"2.19","lowerLimit":"2.10","upperLimit":"2.28"}]}]}]},{"type":"SECONDARY","title":"Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries","description":"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.\n\nHot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"week 4 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.59","lowerLimit":"-0.73","upperLimit":"-0.45"},{"groupId":"OG001","value":"-0.29","lowerLimit":"-0.41","upperLimit":"-0.16"}]}]}]},{"type":"PRIMARY","title":"Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.\n\nHot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"week 4 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.43","lowerLimit":"-0.54","upperLimit":"-0.33"},{"groupId":"OG001","value":"-0.23","lowerLimit":"-0.34","upperLimit":"-0.13"}]}]}]},{"type":"PRIMARY","title":"Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries","description":"Change in daily hot flash severity between baseline \\& week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"week 8 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","lowerLimit":"-0.64","upperLimit":"-0.40"},{"groupId":"OG001","value":"-0.30","lowerLimit":"-0.42","upperLimit":"-0.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).","statisticalMethod":"Regression, Linear","statisticalComment":"Natural log transformations applied to hot flash frequencies for modeling assumptions."}]},{"type":"SECONDARY","title":"Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries","description":"Change in daily hot flash bother between baseline \\& week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).","populationDescription":"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).\n\nModified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Scores on a scale","timeFrame":"week 8 minus baseline","groups":[{"id":"OG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week."},{"id":"OG001","title":"Placebo","description":"Inactive pill"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"96"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.63","lowerLimit":"-0.78","upperLimit":"-0.49"},{"groupId":"OG001","value":"-0.39","lowerLimit":"-0.55","upperLimit":"-0.24"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","statisticalMethod":"Regression, Linear"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Adverse events were collected during the 8 week treatment period.","description":"Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.","eventGroups":[{"id":"EG000","title":"Escitalopram","description":"Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.","seriousNumAffected":0,"seriousNumAtRisk":104,"otherNumAffected":54,"otherNumAtRisk":104},{"id":"EG001","title":"Placebo","description":"Inactive pill","seriousNumAffected":0,"seriousNumAtRisk":101,"otherNumAffected":62,"otherNumAtRisk":101}],"otherEvents":[{"term":"Fatigue, tiredness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":14,"numAtRisk":104},{"groupId":"EG001","numEvents":14,"numAffected":14,"numAtRisk":101}]},{"term":"Difficulty sleeping/insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":104},{"groupId":"EG001","numEvents":10,"numAffected":10,"numAtRisk":101}]},{"term":"Drowsiness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":14,"numAffected":14,"numAtRisk":104},{"groupId":"EG001","numEvents":13,"numAffected":13,"numAtRisk":101}]},{"term":"Increased sweating","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":104},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":101}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":104},{"groupId":"EG001","numEvents":12,"numAffected":12,"numAtRisk":101}]},{"term":"Stomach or intestinal problems","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":10,"numAtRisk":104},{"groupId":"EG001","numEvents":18,"numAffected":18,"numAtRisk":101}]},{"term":"Nausea or vomiting","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":104},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":101}]},{"term":"Decreased sexual desire/ability","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":104},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":101}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":104},{"groupId":"EG001","numEvents":11,"numAffected":11,"numAtRisk":101}]},{"term":"Vivid dreams","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":104},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":101}]},{"term":"Appetite changes","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":104},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":101}]},{"term":"Other symptoms","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":104},{"groupId":"EG001","numEvents":10,"numAffected":10,"numAtRisk":101}]},{"term":"Dizziness/lightheadedness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":104},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":101}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Although this was a community-based sample, the volunteers may be a select group motivated to seek treatment. An 8-week trial is brief, but data indicate that this interval is sufficient to determine long-term efficacy of a nonhormonal compound."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Ellen W. Freeman","organization":"University of Pennsylvania School of Medicine","email":"freemane@mail.med.upenn.edu","phone":"215-349-5521"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019584","term":"Hot Flashes"}],"ancestors":[{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}