Identifying Oxytocin Deficiency in Adults With Pituitary Disease

May 11, 2026 updated by: Elizabeth Austen Lawson

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arginine-vasopressin deficiency
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency
Drug: Norethindrone Acetate-Ethinyl Estradiol
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
Other Names:
  • Estrogen-progestin
Experimental: Healthy control
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.
Drug: Norethindrone Acetate-Ethinyl Estradiol
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
Other Names:
  • Estrogen-progestin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time points: time 0 min (baseline) and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From time 0 min (baseline) to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Austen Lawson

Investigators

  • Principal Investigator: Elizabeth A Lawson, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2024

Primary Completion (Actual)

March 17, 2026

Study Completion (Actual)

March 17, 2026

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P001090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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