RecruitingEarly Phase 1NCT06460948

Identifying Oxytocin Deficiency in Adults With Pituitary Disease

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


Sponsor

Elizabeth Austen Lawson

Enrollment

32 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • AVD Group:
  • Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
  • Healthy Control Group Adults 16-65 years old

Exclusion Criteria3

  • 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

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Interventions

DRUGNorethindrone Acetate-Ethinyl Estradiol

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


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06460948


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