Testing Oral Norethindrone Acetate-Ethinyl Estradiol to Detect Oxytocin Deficiency in Youth With Hypopituitarism

What this Trial Is About

Researchers are conducting an open-label pilot trial to study youth aged 7 to 21 years with arginine-vasopressin deficiency AVP-D and pediatric patients with hypopituitarism. The study aims to identify if oral estrogenprogestin stimulates oxytocin release, focusing on oxytocin deficiency diagnosis and neuropsychological characteristics such as anxiety, mood, impulse control, and social functioning. Participants include those with AVP-D and matched controls without AVP-D, recruited from Massachusetts General Hospital and the community. Participants will receive a single oral dose of two tablets containing 1 mg norethindrone acetate and 70 mcg ethinyl estradiol. The treatment is given to both groups participants with AVP-D and control subjects with hypopituitarism. Blood and saliva samples will be collected at baseline and about 24 hours after drug administration to measure changes in neurophysin-1 and oxytocin. Neuropsychological assessments will be completed at baseline to characterize participants. Throughout the study, participants will undergo assessments of hormone levels and neuropsychological tests to evaluate anxiety, mood, eating behaviors, social cognition, and quality of life. Sampling for blood and saliva occurs twice, at baseline and 24 hours post-treatment. The trial runs from August 2026 to April 2027, with the primary outcome focusing on changes in neurophysin-1. Safety and eligibility monitoring will also be conducted during participation.

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease