[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oxytocin-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oxytocin-deficiency":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Arginine Vasopressin Deficiency","Oxytocin Deficiency","Pediatric Disease","Hypopituitarism","RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":22},"2026-05",{"date":40,"type":22},"2027-04",{"name":42,"class":43},"Massachusetts General Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100603957","sleep-disorders-in-hypothalamic-and-pituitary-damage-100603957","NCT07143266","Sleep Disorders in Hypothalamic and Pituitary Damage","Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage","SDHPD","Inclusion Criteria:\n\n* Patients with hypothalamic-pituitary dysfunction (HPD) with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage (e.g., arginine-vasopressin deficiency (AVP-D) and\u002For severe obesity and\u002For hyperphagia; MRI suggestive of hypothalamic damage; traumatic brain injury; radiotherapy in the sellar region and\u002For brain tumors affecting the hypothalamus).\n* Healthy controls matched for BMI, age, and sex.\n\nExclusion Criteria:\n\n* Poor control of hormonal deficiencies in the previous 6 months.\n* Use of new psychoactive drugs in the last 3 months or occasional use.\n* Clinically significant liver, lung, kidney, and cardiovascular disease.\n* Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).\n* Uncontrolled diabetes mellitus.\n* Active psychosis.\n* Ophthalmology: total blindness, Glaucoma, uveitis, visual acuity \\\u003C0.6, or eye surgery in the previous 6 months.\n* Any acute illness that the investigator determines may interfere with study participation or safety.\n* Pregnancy or breastfeeding.\n* Patients who refuse or are unable to provide written informed consent.\n* In controls: presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, and history of hypopituitarism.",true,"18 Years","70 Years",{"count":57,"type":22},60,"3 Months","OBSERVATIONAL","Hypothalamus has a key role in multiple vital functions, including regulation of sleep-wake cycles. Oxytocin (OT), a neurohormone synthetized in the hypothalamus, has a wide range of physiological functions, including a putative role in improving sleep quality. Hypothalamic and pituitary damage (HPD) is associated with a clinically relevant OT deficient state and multiple and severe comorbidities including poor sleep quality, that have a well-known negative impact on general health and quality of life (QoL). Several factors may coexist in the pathophysiology of sleep disorders (SD) in HPD and SD might be a keystone in the persistence of some of the comorbidities observed in HPD. Therefore, appropriate identification and understanding of the mechanisms contributing to SD in HPD is mandatory to choose adequate preventive strategies and treatment. This project is aimed to (1) identify the prevalence of SD in HPD, (2) to determine OT role in sleep quality and (3) to identify potential mechanisms and mediators of sleep quality and their associations with clinical outcomes in patients with HPD with the ultimate goal of identifying preventive and therapeutic targets. We will use a controlled cross-sectional design of patients with HPD and sex-, BMI-, age- matched controls and an innovative cross-disciplinary approach bridging neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine and neuroophthalmology disciplines to learn about the prevalence of SD in HPD and to disentangle the underpinning mechanisms behind SDs in HPD. The results of this project will be an extremely important step towards optimizing therapy for patients with HPD who have higher mortality and poor QoL despite appropriate hormone replacement therapy.",[31,62,63,29],"Sleep Wake Disorders","Hypothalamic Diseases",[65,66,31,67],"Sleep Disorder","Oxytocin deficiency","Hypothalamic damage","2025-11-14",{"date":70,"type":36},"2025-11-18",{"date":72,"type":36},"2025-09-01",{"date":74,"type":22},"2027-12",{"name":76,"class":43},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":44},"100578224","phase-2-effects-of-intranasal-oxytocin-on-sexual-well-being-in-patients-with-arginine-vasopressin-deficiency-and-healthy-controls-100578224","NCT06808516","Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls","The OxyPLEASURE Study - Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - a Double-blind Randomized Placebo-controlled Crossover Trial","OxyPLEASURE","Inclusion Criteria for healthy controls:\n\n* Adult healthy volunteers aged 18 years and above\n* Matched for age, sex, BMI, and menopause\u002Fhormonal contraceptives to patients\n* No medication, except hormonal contraception\n* At least mild impairment in sexual function and satisfaction, defined as an ASEX-score ≥10 points and an NSSS-S score ≤ 48 points\n* Only Part A: Participants must be sexually active (at least once a week sexual intercourse) and in a current partnership for at least 6 months\n\nInclusion criteria for patients:\n\n* Adult patients aged 18 years and above, with a confirmed diagnosis of AVP deficiency based on established criteria\n* Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies\n* At least mild impairment in sexual function and satisfaction, defined as an ASEX-score ≥10 points and an NSSS-S score ≤ 48 points\n* Only Part A: Participants must be sexually active (at least once a week sexual intercourse) and in a current partnership for at least 6 months\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding within the last eight weeks\n* Participation in a trial with investigational drugs within 30 days\n* Active substance use disorder within the last six months\n* Consumption of alcoholic beverages \\>15 drinks\u002Fweek\n* Current or previous psychotic disorder (e.g., schizophrenia)",{"count":86,"type":22},42,[88],"PHASE2","The study aims to investigate whether intranasal oxytocin (OXT) improves sexual well-being in patients with Arginine Vasopressin Deficiency (AVP-D). The trial consists of two parts: Part A assesses the effect of OXT on sexual well-being and intimacy over a 7-day treatment period in participants in a stable partnership. Part B assesses the effect of a single dose OXT on sexual arousal, fear and empathy in a clinical setting and is designed for single participants and those in partnerships.",[28,91,29],"Central Diabetes Insipidus",[93,94],"Nasal oxytocin","Sexual Well-Being","2025-09-29",{"date":97,"type":36},"2025-10-03",{"date":99,"type":36},"2025-07-01",{"date":101,"type":22},"2026-12",{"name":103,"class":43},"University Hospital, Basel, Switzerland"]