[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582654":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":42,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Case participants with Primary Ovarian Insufficiency",null,"This group is comprised of women (assigned female at birth), age 30-40yo who have a clinically documented diagnosis of primary ovarian insufficiency (POI) within 6 months and be planning to clinically initiate estrogen replacement therapy (with 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone either 100mg daily or 200mg cyclically) with their own provider. Women in the group may not be on systemic estrogen, progesterone or testosterone therapy, have contraindications for estrogen administration or known atherosclerotic cardiovascular disease or equivalents. They must also not take lipid lowering therapy or antihypertensive or anti-inflammatory\u002Fimmune suppressant medications or be pregnant or breastfeeding. After a telephone screen to determine eligibility, the group will engage in two in-person study visits. The first occurs prior to the initiating estrogen replacement therapy and the second after 6 months of treatment.",{"label":13,"type":10,"description":14,"interventionNames":10},"Health control participants without Primary Ovarian Insufficiency","This group is compromised of women (assigned female at birth), age 30-40yo who have regular menstrual cycles every 21-35 days. Women in the group may not be on systemic estrogen, progesterone or testosterone therapy, have contraindications for estrogen administration or known atherosclerotic cardiovascular disease or equivalents. They must also not take lipid lowering therapy or antihypertensive or anti-inflammatory\u002Fimmune suppressant medications or be pregnant or breastfeeding. After a telephone screen to determine eligibility, the group will in a single in-person study visit.",[16],{"name":17,"affiliation":18,"role":19},"Markella V. Zanni, MD","MGH\u002FHMS","STUDY_CHAIR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Sara L. Stockman, MD, PhD","CONTACT","617-643-4420","sstockman@mgh.harvard.edu",{"name":17,"role":23,"phone":27,"phoneExt":10,"email":28},"617-726-7948","mzanni@mgh.harvard.edu",[30],{"facility":5,"status":10,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"Boston","Massachusetts","02114","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-71.05977,42.35843,{"lat":40,"lon":39},{"type":43,"investigatorFullName":22,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Endocrine Fellow","100582654","effects-of-estrogen-on-heart-health-in-women-with-primary-ovarian-insufficiency-100582654",false,"NCT06866119","Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency","Effects of Estrogen Replacement on Cardiometabolic Endpoints in Women With Primary Ovarian Insufficiency","ENCODE","Inclusion criteria (I):\n\n* female sex\n* age 30-40\n* CASE PARTICIPANTS ONLY: clinically documented POI diagnosis within 6 months\n* CASE PARTICIPANTS ONLY: planning to clinically initiate 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone (either 100mg daily or 200mg cyclically)\n* CONTROL PARTICIPANTS ONLY: regular menstrual cycles every 21-35 days\n\nExclusion criteria (E):\n\n* CASE PARTICIPANTS ONLY: genetic POI etiology\n* CASE PARTICIPANTS ONLY: any prior initiation of ERT\n* systemic estrogen, progesterone or testosterone therapy within the past 6 months (including contraception, except for locally acting intrauterine devices - IUDs)\n* lipid lowering therapy within the past 6 months\n* use of antihypertensive medication within the past 6 months\n* current treatment with prescription, systemic (oral, IV, or IM) steroids or anti-inflammatory\u002Fimmune suppressant medical therapies (excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune\u002Finflammatory diseases (psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes\n* use of oral steroids or prescription oral anti-inflammatory\u002Fimmune suppressant medication for \\>7 days within the past 1 month\n* use of IV or IM steroids or IV or IM anti-inflammatory\u002Fimmune suppressant medication within the past 3 months\n* self-reported history of breast and\u002For estrogen dependent malignancy\n* self-reported history of deep vein thromboembolism, pulmonary embolism or stroke\n* self-reported severe liver disease such as cirrhosis\n* self-reported hypercoagulable disorder\n* uncontrolled hypertension at baseline Visit #1- systolic blood pressure (SBP) ≥180 and\u002For diastolic blood pressure (DBP) ≥110\n* tobacco use within 6 months\n* self-reported history of myocardial infarction, stroke, coronary revascularization or diabetes as a CVD risk equivalent\n* stable or unstable angina\n* self-reported history of heart failure\n* pregnancy or breastfeeding\n* concurrent enrollment in conflicting research study",true,"FEMALE","30 Years","40 Years",{"count":58,"type":59},45,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to study the effects of treating women with Primary Ovarian Insufficiency (POI) with estrogen replacement therapy to bolster the evidence backing cardiometabolic preventive care in women with POI. The main question it aims to answer is:\n\nDoes 6 months of estrogen replacement therapy for women with POI improved markers of heart health?\n\nWomen newly diagnosed with POI (within 6 months) who are planning to start estrogen replacement therapy from their clinical provider will undergo assessment of markers of heart health before and after 6 months of treatment. These markers will also be compared to those obtained from healthy women without POI.",[63,64,65,66,67],"Primary Ovarian Insufficiency","Premature Menopause","Metabolic Complications","Endothelial Function (FMD)","Estrogen Replacement Therapy",[69,70,71,72,73,74],"primary ovarian insufficiency","premature menopause","estrogen replacement therapy","cardiovascular disease prevention","POI","ERT","NOT_YET_RECRUITING","2026-01-05",{"date":78,"type":79},"2026-01-07","ACTUAL",{"date":81,"type":59},"2026-03-01",{"date":83,"type":59},"2026-06",{"name":5,"class":6},1]