Actively Recruiting
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Led by Massachusetts General Hospital · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. This study tests the hypothesis that oral estrogen/progestin will stimulate endogenous oxytocin release in control subjects. Eligible participants will receive two tablets in a single administration containing a total of 1 mg of norethindrone acetate 70 mcg of ethinyl estradiol. Sampling for blood and saliva will take place at baseline and approximately 24 hours following study drug administration. Neuropsychological assessment (anxiety, mood and emotion regulation; impulse control; aberrant eating behaviors; social cognition and functioning; quality of life) will be assessed at baseline to characterize the study population.
CONDITIONS
Official Title
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with arginine vasopressin deficiency using standard clinical tools
- Stable pituitary hormone replacement with no changes in dose for 6 weeks before baseline
- Female participants on estrogen/progestin must agree to stop for at least 6 weeks before study visits
- Diagnosis of hypopituitary disease
- Participants with hormone replacement must have no dose changes in 6 weeks before baseline
- English language proficiency
You will not qualify if you...
- History of pulmonary embolism or unprovoked deep venous thrombosis
- History of breast or endometrial cancer or current use of estrogen modulators/blockers like tamoxifen, raloxifene, or aromatase inhibitors
- History of stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease
- Pregnancy or breastfeeding within the last 8 weeks
- Medication changes within 2 weeks before enrollment or within 5 half-lives of the medication
- History of stage 3 chronic kidney disease or cirrhosis
- Any significant illness or condition that might interfere with participation or safety as determined by the investigator
- Active tobacco smoking or use of nicotine patches
- Psychosis or active suicidality
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
H
Hannah Lamont, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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