Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07568509
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Arginine Vasopressin Deficiency
  • Hypopituitarism
  • Oxytocin Deficiency
  • Pediatric Disease

Eligibility Criteria

Sex
ALL
Age
7 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Norethindrone Acetate-Ethinyl Estradiol — DRUG
    Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.

Study Details

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 Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D).
    Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency.
  • Experimental: Individuals with hypopituitary disease (without AVP-D)
    Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects.

Primary Outcome Measure

Change in neurophysin-1 from baseline [ Time Frame: 0 minutes (Baseline) and 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Hannah Lamont, PhD
[email protected]
617-726-1347

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By research site
Massachusetts General Hospital· Boston, MA

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