Arginine Vasopressin Deficiency, Oxytocin Deficiency
Conditions
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.
Interventions
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
Sponsors
Elizabeth Austen Lawson
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peripheral oxytocin concentration from 0 to 24 hours | Time points: time 0 min (baseline) and 24 hours | Change in peripheral oxytocin concentration from 0 to 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From time 0 min (baseline) to 48 hours | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth A Lawson, MD
Massachusetts General Hospital
Outcome results
None listed