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Identifying Oxytocin Deficiency in Adults With Pituitary Disease

NCT06460948 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-13

No results posted yet for this study

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

DRUG

Norethindrone Acetate-Ethinyl Estradiol

Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Sponsors & Collaborators

  • Elizabeth Austen Lawson

    lead OTHER

Principal Investigators

  • Elizabeth A Lawson, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-03-17
Completion
2026-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06460948 on ClinicalTrials.gov