[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649224":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":46,"locations":53,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":31,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":103,"whyStopped":31,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Yale University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose Oxytocin","EXPERIMENTAL","Participants in this arm will receive low dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[13],"Drug: Oxytocin (Low dose)",{"label":15,"type":10,"description":16,"interventionNames":17},"High Dose Oxytocin","Participants in this arm will receive high dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[18],"Drug: Oxytocin (High dose)",{"label":20,"type":21,"description":22,"interventionNames":23},"Saline-Mg solution","PLACEBO_COMPARATOR","Participants in this arm will receive placebo beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[24],"Drug: Placebo (saline)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Oxytocin (Low dose)","The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Oxytocin (High dose)","The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo (saline)","Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[20],[41,44],{"name":42,"affiliation":5,"role":43},"S. Bulent Omay, MD","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":5,"role":43},"Helena Rutherford, PhD",[47,51],{"name":42,"role":48,"phone":49,"phoneExt":31,"email":50},"CONTACT","203-737-6885","sacit.omay@yale.edu",{"name":45,"role":48,"phone":31,"phoneExt":31,"email":52},"helena.rutherford@yale.edu",[54],{"facility":5,"status":31,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"New Haven","Connecticut","06510","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-72.92816,41.30815,{"lat":64,"lon":63},[67,68,69,70],{"name":42,"role":48,"phone":49,"phoneExt":31,"email":50},{"name":45,"role":48,"phone":31,"phoneExt":31,"email":52},{"name":42,"role":43,"phone":31,"phoneExt":31,"email":31},{"name":45,"role":43,"phone":31,"phoneExt":31,"email":31},{"type":43,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Sacit Omay","Associate Professor of Neurosurgery and Otolaryngology",[75],{"name":76,"class":77},"Tonix Pharmaceuticals, Inc.","INDUSTRY","100649224","phase-2-evaluating-intranasal-oxytocin-tnx-1900-for-pain-relief-and-recovery-after-pituitary-surgery-100649224",false,"NCT07730294","Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery","Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery","Inclusion Criteria:\n\n* Age: Between 30 to 75 years old.\n* Consent: Ability to give informed consent.\n* Language: Proficiency in the English language.\n* Medical Condition: Diagnosed with a pituitary lesion requiring surgery.\n* Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).\n\nExclusion Criteria:\n\n* Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.\n* Neurological Conditions: A history of seizures, current use of anticonvulsants.\n* Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.\n* Any history of renal impairment (serum creatinine \\>1.2 x ULN)\n* Any history of hepatic impairment (AST and\u002For ALT \\>2 x ULN)\n* Surgical History: Any history of previous pituitary surgery procedures\n* Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.\n* Any known hypersensitivity to TNX-1900","ALL","30 Years","75 Years",{"count":89,"type":90},75,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.",[96,97],"Pain","Pituitary Surgery",[99,100,101,102],"pain","pain perception","oxytocin","intranasal","NOT_YET_RECRUITING","2026-07-23",{"date":106,"type":107},"2026-07-28","ACTUAL",{"date":109,"type":90},"2026-08",{"date":111,"type":90},"2028-08",{"name":5,"class":6},1]