[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636655":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":53,"collaborators":35,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":35,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":35,"overallStatus":39,"whyStopped":35,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D).","EXPERIMENTAL","Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency.",[13],"Drug: Norethindrone Acetate-Ethinyl Estradiol",{"label":15,"type":10,"description":16,"interventionNames":17},"Individuals with hypopituitary disease (without AVP-D)","Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Norethindrone Acetate-Ethinyl Estradiol","Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.",[15,9],[25],"Estrogen-progestin",[27],{"name":28,"affiliation":5,"role":29},"Elizabeth A Lawson, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Hannah Lamont, PhD","CONTACT","617-726-1347",null,"MGHHypopit@MGH.HARVARD.EDU",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Elizabeth Austen Lawson","Associate Professor of Medicine","100636655","early-phase-1-identifying-oxytocin-deficiency-in-pediatric-patients-with-pituitary-disease-100636655",false,"NCT07568509","Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease","Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism","Pedi-EVOLVE","Inclusion criteria (participants with AVP-D):\n\n* AVP-D diagnosed in clinic using standard of care diagnostic tools;\n* Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline);\n* If on estrogen\u002Fprogestin, female participants agree to stop for at least 6 weeks prior to Main study visits;\n* English language proficiency.\n\nInclusion criteria (participants with hypopituitary disease):\n\n* Hypopituitary disease diagnosis;\n* If receiving pituitary hormone replacement, no change in dose in six weeks prior to baseline);\n* If on estrogen\u002Fprogestin, participants agree to stop for at least 6 weeks prior to Main study visits;\n* English language proficiency.\n\nExclusion criteria (all participants):\n\n* History of pulmonary embolism or unprovoked deep venous thrombosis;\n* History of breast\u002Fendometrial cancer as well as current therapies on estrogen modulators\u002Fblockers (i.e., tamoxifen, raloxifene, aromatase inhibitors);\n* History of stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;\n* Pregnancy or breastfeeding within the last 8 weeks;\n* Medication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;\n* History of stage 3 chronic kidney disease or cirrhosis;\n* Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety;\n* Active tobacco smoking or nicotine patch use;\n* Psychosis or active suicidality.","ALL","7 Years","21 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"EARLY_PHASE1","An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. This study tests the hypothesis that oral estrogen\u002Fprogestin will stimulate endogenous oxytocin release in control subjects. Eligible participants will receive two tablets in a single administration containing a total of 1 mg of norethindrone acetate 70 mcg of ethinyl estradiol. Sampling for blood and saliva will take place at baseline and approximately 24 hours following study drug administration. Neuropsychological assessment (anxiety, mood and emotion regulation; impulse control; aberrant eating behaviors; social cognition and functioning; quality of life) will be assessed at baseline to characterize the study population.",[75,76,77,78],"Arginine Vasopressin Deficiency","Oxytocin Deficiency","Pediatric Disease","Hypopituitarism","2026-05-12",{"date":81,"type":82},"2026-05-15","ACTUAL",{"date":84,"type":69},"2026-05",{"date":86,"type":69},"2027-04",{"name":5,"class":6},1]