DRUG
Norethindrone Acetate-Ethinyl Estradiol
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Status
Completed
Phase
Early Phase 1
Enrollment
28
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 14, 2024
Study start
Nov 13, 2024
Primary completion
Mar 17, 2026
Study completion
Mar 17, 2026
Results posted
Not reported
Registry updated
May 13, 2026
Outcomes
What the study measures.
Primary outcomes
Change in peripheral oxytocin concentration from 0 to 24 hours
Time frame · Time points: time 0 min (baseline) and 24 hours
Change in peripheral oxytocin concentration from 0 to 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
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Vasopressin.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Wake Forest University Health Sciences · Total Hip Arthroplasty
Phase 2
Enrolling by invitation
80
2026-07
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Yale University · Pain · Pituitary Surgery
Phase 2
Not yet recruiting
75
2026-07
Oxytocin to Enhance Integrated Treatment for AUD and PTSD
Medical University of South Carolina · PTSD · Alcohol Use Disorder
Phase 2
Completed
175
2026-07
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
University Hospital, Tours · Cervical Ripening · Unfavorable Cervix
Phase 3
Recruiting
1,494
2026-07
Different Medications to Induce Labor
Icahn School of Medicine at Mount Sinai · Pregnancy · Labor
Phase 3
Recruiting
281
2026-07
Mifepristone vs Misoprostol
Montefiore Medical Center · Cervical Preparation
Phase 1
Recruiting
94
2026-07
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.