Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Elizabeth Austen Lawson
Study ID
NCT06460948
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Arginine Vasopressin Deficiency
  • Oxytocin Deficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
May 2026
Primary completion
Mar 17, 2026
Completion
Mar 17, 2026

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Change in peripheral oxytocin concentration from 0 to 24 hours [ Time Frame: Time points: time 0 min (baseline) and 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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