Identifying Oxytocin Deficiency in Adults With Pituitary Disease

NCT06460948 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2024P001090
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 1.Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
2. 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.

Conditions

Arginine Vasopressin Deficiency; Oxytocin Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in peripheral oxytocin concentration from 0 to 24 hours

  Change in peripheral oxytocin concentration from 0 to 24 hours

  Time points: time 0 min (baseline) and 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

  From time 0 min (baseline) to 48 hours

Study Arms (2)

Arginine-vasopressin deficiency

EXPERIMENTAL

Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency

Drug: Norethindrone Acetate-Ethinyl Estradiol

Healthy control

EXPERIMENTAL

Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.

Drug: Norethindrone Acetate-Ethinyl Estradiol

Interventions

Norethindrone Acetate-Ethinyl Estradiol DRUG

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

Also known as: Estrogen-progestin

Arginine-vasopressin deficiency; Healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Austen Lawson: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic

Interventions

norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Condition Hierarchy (Ancestors)

Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Elizabeth A Lawson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Galbiati, MD

CONTACT

617-726-3870; fgalbiati@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)