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Completed

NCT Number: NCT06460948

Identifying Oxytocin Deficiency in Adults With Pituitary Disease

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.

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Key information

Conditions

Arginine Vasopressin Deficiency Diabetes Insipidus Diabetes Insipidus, Neurogenic Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Oxytocin Deficiency Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norethindrone Acetate-Ethinyl Estradiol

Drug

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

Other names: Estrogen-progestin

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Elizabeth Austen Lawson

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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