Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Oxytocin Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460948
• Other study ID #: 2024P001090
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: Francesca Galbiati, MD
• Phone: 617-726-3870
• Email: fgalbiati[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Oxytocin Deficiency

Intervention

Drug:
• Norethindrone Acetate-Ethinyl Estradiol
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Austen Lawson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peripheral oxytocin concentration from 0 to 24 hours	Change in peripheral oxytocin concentration from 0 to 24 hours	Time points: time 0 min (baseline) and 24 hours
Secondary	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	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.	From time 0 min (baseline) to 48 hours