NCT06460948

Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Elizabeth Austen Lawson · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arginine Vasopressin Deficiency
• Oxytocin Deficiency

Interventions

Type	Name	Description
DRUG	Norethindrone Acetate-Ethinyl Estradiol	Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-06-14
• Last updated: 2025-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study