RecruitingEarly Phase 1NCT07568509

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism


Sponsor

Massachusetts General Hospital

Enrollment

20 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Norethindrone Acetate-Ethinyl Estradiol for people with arginine vasopressin deficiency, hypopituitarism, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 7 Years to 21 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNorethindrone Acetate-Ethinyl Estradiol

Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07568509


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