NCT06460948 Identifying Oxytocin Deficiency in Adults With Pituitary Disease
| NCT ID | NCT06460948 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Elizabeth Austen Lawson |
| Condition | Arginine Vasopressin Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2026-06 |
Trial Parameters
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Brief Summary
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that: 1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control. 2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
Eligibility Criteria
Inclusion Criteria: * AVD Group: Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement * Healthy Control Group Adults 16-65 years old Exclusion Criteria for all participants: * History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease * Pregnancy or breastfeeding within last 8 weeks * Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety