Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Recruiting now · Early Phase 1
Conditions studied: Arginine Vasopressin Deficiency, Oxytocin Deficiency, Pediatric Disease, Hypopituitarism
In brief
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.
Key facts
- Study ID
- NCT07568509
- Run by
- Massachusetts General Hospital
- People needed
- 20
- Starts
- 2026-08-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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