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Recruiting NCT07568509

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Early Phase I Interventional Arginine Vasopressin Deficiency Oxytocin Deficiency Pediatric Disease Hypopituitarism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norethindrone Acetate-Ethinyl Estradiol.
Who it may be relevant to
Registry conditions: Arginine Vasopressin Deficiency, Oxytocin Deficiency, Pediatric Disease, Hypopituitarism. Basic parameters: 7 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Change in neurophysin-1 from baseline [Time frame: 0 minutes (Baseline) and 24 hours]
Secondary outcome measures (1)
  • Change in oxytocin from baseline [Time frame: 0 minutes (Baseline) and 24 hours]

Eligibility criteria

Inclusion criteria (participants with AVP-D):

  • AVP-D diagnosed in clinic using standard of care diagnostic tools;
  • Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline);
  • If on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits;
  • English language proficiency.

Inclusion criteria (participants with hypopituitary disease):

  • Hypopituitary disease diagnosis;
  • If receiving pituitary hormone replacement, no change in dose in six weeks prior to baseline);
  • If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits;
  • English language proficiency.

Exclusion criteria (all participants):

  • History of pulmonary embolism or unprovoked deep venous thrombosis;
  • History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, aromatase inhibitors);
  • History of stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;
  • Pregnancy or breastfeeding within the last 8 weeks;
  • Medication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;
  • History of stage 3 chronic kidney disease or cirrhosis;
  • Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety;
  • Active tobacco smoking or nicotine patch use;
  • Psychosis or active suicidality.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07568509 · 2025P001958

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗