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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• AVD Group:

⁃ Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement

• Healthy Control Group Adults 16-65 years old

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Francesca Galbiati, MD
fgalbiati@bwh.harvard.edu
617-726-3870
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2026-06
Participants
Target number of participants: 32
Treatments
Experimental: Arginine-vasopressin deficiency
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency
Experimental: Healthy control
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.
Sponsors
Leads: Elizabeth Austen Lawson

This content was sourced from clinicaltrials.gov

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