[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579627":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler.",[13],"Dietary Supplement: Placebo",{"label":15,"type":6,"description":16,"interventionNames":17},"Melatonin","Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women.",[18],"Dietary Supplement: Terry Naturally® melatonin 5mg SR",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Terry Naturally® melatonin 5mg SR","Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.",[15],null,{"type":21,"name":9,"description":23,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"affiliation":5,"role":31},"Naima Covassin, Ph.D.","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Perimenopause Study Team","CONTACT","507-255-8897","PerimenopauseStdy@mayo.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-92.4699,44.02163,{"lat":51,"lon":50},[54,56],{"name":30,"role":35,"phone":25,"phoneExt":25,"email":55},"Covassin.Naima@mayo.edu",{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"type":31,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Naima Covassin","Principal Investigator","100579627","melatonin-effects-on-cardiovascular-disease-mechanisms-in-midlife-women-a-randomized-clinical-trial-100579627",false,"NCT06826755","Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial","Inclusion Criteria\n\n* Age 40-55 years old\n* Female individuals with intact uterus and at least one ovary\n* Hypertension\n\n  o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP\u002FDBP ≥130\u002F80 mmHg\n* On stable medical regimen (≥ 2 months) if taking other medications\n\nExclusion Criteria\n\n* Prescription sleeping medications or melatonin supplementation\n* Pregnant or lactating\n* Use of tobacco, nicotine or vaping products\n* Night shift work\n* On prescription aspirin\n* Severe lactose intolerance\n* History of substance use disorder\n* History of suicidal ideation\n* History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\\\u003C11.6 g\u002FdL) within the past 12 months\n* Active cancer\n* Severe daytime sleepiness (score \\>15 at the Epworth Sleepiness Scale \\[ESS\\])81\n* Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators\n* Inability to provide written consent and\u002For to speak and read English\n* Any other medical, geographic, or social factor making study participation impractical","FEMALE","40 Years","55 Years",{"count":70,"type":71},70,"ESTIMATED","INTERVENTIONAL",[74],"NA","The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.",[77,78],"Perimenopause","Hypertension","2025-11-19",{"date":81,"type":82},"2025-11-24","ACTUAL",{"date":84,"type":82},"2025-05-23",{"date":86,"type":71},"2027-01",{"name":5,"class":6},1]