Actively Recruiting
Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism
Led by Massachusetts General Hospital · Updated on 2026-05-15
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oxytocin deficiency in young people with pituitary disease, specifically arginine vasopressin deficiency (AVP-D) and hypopituitarism. This early-phase interventional pilot trial aims to test whether oral estrogen/progestin stimulates natural oxytocin release in control subjects. The study recruits 20 youth aged 7 to 21 years matched for age, sex, and BMI from a pediatric endocrinology and neuroendocrinology setting and the community. Participants will receive a single dose of two tablets containing 1 mg norethindrone acetate and 70 mcg ethinyl estradiol. This oral treatment is given to both the AVP-D group and the control group. Blood and saliva samples will be collected before treatment and about 24 hours after administration. Baseline neuropsychological assessments will evaluate anxiety, mood, impulse control, eating behaviors, social functioning, and quality of life to better understand the participants. During the study, participants will undergo blood and saliva sampling at baseline and 24 hours post-treatment to measure changes in neurophysin-1 and oxytocin levels. The initial neuropsychological evaluation characterizes mental and emotional health. The study will monitor these biological and psychological outcomes without masking or randomization. The total duration of participation is brief, focused on assessing the hormonal response and neuropsychological status.
CONDITIONS
Brief Title
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed arginine-vasopressin deficiency (AVP-D) using standard clinical tools
- Stable pituitary hormone replacement without dose changes for at least 6 weeks prior to baseline
- Female participants on estrogen/progestin agree to stop for at least 6 weeks before study visits
- English language proficiency
- Diagnosed hypopituitary disease
- If on pituitary hormone replacement, no dose changes for at least 6 weeks prior to baseline
- Participants on estrogen/progestin agree to stop for at least 6 weeks before study visits
- 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, heart attack, angina, or peripheral arterial disease
- Pregnancy or breastfeeding within the last 8 weeks
- Medication changes within 2 weeks of enrollment or within 5 half-lives of the medication
- History of stage 3 chronic kidney disease or cirrhosis
- Any significant illness or condition interfering with participation or safety
- Active tobacco smoking or nicotine patch use
- Psychosis or active suicidality
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment not specified
Participants receive Norethindrone Acetate-Ethinyl Estradiol as part of the study intervention.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
H
Hannah Lamont, PhD
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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