RecruitingEarly Phase 1

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

United States20 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range

7 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria (participants with AVP-D): * AVP-D diagnosed in clinic using standard of care diagnostic tools; * Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline); * If on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits; * English language proficiency. Inclusion criteria (participants with hypopituitary disease): * Hypopituitary disease diagnosis; * If receiving pituitary hormone replacement, no change in dose in six weeks prior to baseline); * If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits; * English language proficiency. Exclusion criteria (all participants): * History of pulmonary embolism or unprovoked deep venous thrombosis; * History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, 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 of enrollment or within 5 half-lives of the respective medication; * History of stage 3 chronic kidney disease or cirrhosis; * Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety; * Active tobacco smoking or nicotine patch use; * Psych…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in neurophysin-1 from baseline

Timeframe: 0 minutes (Baseline) and 24 hours

Trial details

NCT IDNCT07568509

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Hannah Lamont, PhD

617-726-1347 MGHHypopit@MGH.HARVARD.EDU

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