[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591029":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":73,"centralContacts":77,"locations":86,"responsibleParty":101,"collaborators":43,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":43,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":43,"studyType":116,"phases":117,"briefSummary":120,"conditions":121,"keywords":43,"overallStatus":89,"whyStopped":43,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,16,24,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Preventative Health Advice","EXPERIMENTAL","Participants will be given preventative health advice and asked to wear an activity \\& sleep monitor.",[13,14,15],"Behavioral: Life style intervention","Drug: Fezolinetant","Drug: Hormonal therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"At Risk for Heart Disease","ACTIVE_COMPARATOR","Medications will be given to each participant in this arm that lowers your heart disease risk.",[21,22,23,13],"Drug: Metformin","Drug: Anti-hypertensives","Drug: Lipid Lowering Medication",{"label":25,"type":18,"description":26,"interventionNames":27},"Overweight Women","Women who fit in this category will receive medication for lowering insulin resistance and\u002For a weight loss medication.",[21,28],"Drug: semaglutide",{"label":30,"type":18,"description":31,"interventionNames":32},"Women with Obesity","Women that are over a BMI of 30 kg\u002Fm2 will be offered a GLP-1 antagonist.",[28],{"label":34,"type":18,"description":35,"interventionNames":36},"Women With Hot Flashes","Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and\u002For severity of hot flashes.",[14,15],[38,44,48,54,60,65,69],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Metformin","Metformin will be given to participants who have a elevated HbA1c and also for weightloss.",[17,25],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"semaglutide","Overweight women and women with obesity will take Semaglutide for weight-loss",[25,30],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Anti-hypertensives","a. Antihypertensives, with the goal of maintaining blood pressure at 130\u002F80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.",[17],[53],"The use of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic.",{"type":39,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Lipid Lowering Medication",". First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.",[17],[59],"The use of generic statins",{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":43},"BEHAVIORAL","Life style intervention","will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.",[17,9],{"type":39,"name":66,"description":67,"armGroupLabels":68,"otherNames":43},"Fezolinetant","Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.",[9,34],{"type":39,"name":70,"description":71,"armGroupLabels":72,"otherNames":43},"Hormonal therapy","Participants will be treated with estrogen and\u002For progesterone for treatment of hot flashes in women during the study.",[9,34],[74],{"name":75,"affiliation":5,"role":76},"Nanette Santoro, MD","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":43,"email":82},"Carrie Hsu, BA","CONTACT","303-724-5276","carrie.hsu@cuanschutz.edu",{"name":84,"role":80,"phone":43,"phoneExt":43,"email":85},"Nalia Naushad","naila.naushad@cuanschutz.edu",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":43},"University of Colorado-School of Medicine","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-104.83192,39.72943,{"lat":99,"lon":98},{"type":102,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100591029","phase-2-focusing-on-the-menopausal-transition-to-improve-mid-life-womens-health-100591029",false,"NCT06975111","Focusing on the Menopausal Transition to Improve Mid-Life Women's Health","Inclusion Criteria:\n\n* aged 45-55\n* In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18\n* No current use of hormone therapy or hormonal contraception\n* Presence of a uterus and at least one ovary in order to track menstrual patterns\n* Have a smartphone and broadband access adequate to accept telehealth appointments\n\nExclusion Criteria:\n\n* Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)\n* Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.\n* Pregnancy or actively trying to get pregnant\n* Inability to adhere to study protocol schedule\n* Untreated alcoholism\n* Un- Diagnosed abnormal uterine bleeding\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\\> 30 kg\u002Fm2.",true,"FEMALE","45 Years","55 Years",{"count":114,"type":115},200,"ESTIMATED","INTERVENTIONAL",[118,119],"PHASE2","PHASE3","What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.",[122,123,124,125],"Menopause","Menopause Hot Flashes","Menopause Related Conditions","Cardiovascular","2026-04-24",{"date":128,"type":129},"2026-04-30","ACTUAL",{"date":131,"type":129},"2026-03-01",{"date":133,"type":115},"2030-10-01",{"name":5,"class":6},1]