Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Early Phase 1RecruitingNCT06460948

Elizabeth Austen Lawson32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Arginine Vasopressin Deficiency Oxytocin Deficiency

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in peripheral oxytocin concentration from 0 to 24 hours

Time frame: Time points: time 0 min (baseline) and 24 hours

Secondary Outcomes

Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls

Difference from baseline to oxytocin peak (blood and saliva) between patients with arginine-vasopressin deficiency compared to healthy controls. Correlation between oxytocin area under the curve and psychopathology and quality of life measures across groups.

Time frame: From time 0 min (baseline) to 48 hours