drugset / Trial / NCT07568509

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

NCT07568509

Phase 0 Recruiting 20 enrolled Massachusetts General Hospital
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2026-05
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Norethindrone Unknown 1 mg Oral
Subject ethinyl estradiol Small molecule 70 ug Oral