Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Early Phase 1

Recruiting

• Conditions: Arginine Vasopressin Deficiency; Oxytocin Deficiency
• Interventions: Drug: Norethindrone Acetate-Ethinyl Estradiol

• Registration Number: NCT06460948
• Lead Sponsor: Elizabeth Austen Lawson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Study Start: 2024-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arginine-vasopressin deficiency	Norethindrone Acetate-Ethinyl Estradiol	Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency
Healthy control	Norethindrone Acetate-Ethinyl Estradiol	Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States