Mass General - Division of Clinical Research

Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Purpose

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.

Conditions

Arginine Vasopressin Deficiency
Oxytocin Deficiency

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: Early Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

Contact:
Francesca Galbiati, MD

More Details

Status: Recruiting
Sponsor: Elizabeth Austen Lawson

Study Contact

Francesca Galbiati, MD
617-726-3870
fgalbiati@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.