Clinical Trial

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Study acronym: Pedi-EVOLVE
Recruiting Early Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-04-28; most recent amendment 2026-07-21.
Trial Details
NCT Number NCT07568509
Lead Sponsor Massachusetts General Hospital
Conditions Arginine Vasopressin Deficiency, Oxytocin Deficiency, Pediatric Disease, Hypopituitarism
Enrollment 20 participants
Start Date 2026-08
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-23