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RECRUITING
NCT07568509
EARLY_PHASE1

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Sponsor: Massachusetts General Hospital

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.

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

Key Details

Gender

All

Age Range

7 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-08

Completion Date

2027-04

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Norethindrone 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