Current partner codePEPTIDESDE
NCT07568509·Early Phase 1·INTERVENTIONAL

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Status

Recruiting

Phase

Early Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Norethindrone Acetate-Ethinyl Estradiol

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

Timeline

From registration to results.

  1. First posted

    May 5, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Apr 2027

  4. Study completion

    Apr 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 23, 2026

Outcomes

What the study measures.

Primary outcomes

Change in neurophysin-1 from baseline

Time frame · 0 minutes (Baseline) and 24 hours

Change in neurophysin-1 levels from baseline to 24 hours

Secondary outcomes

Change in oxytocin from baseline

Time frame · 0 minutes (Baseline) and 24 hours

Change in oxytocin from baseline to 24 hours

Eligibility

Who can take part.

Minimum age
7 Years
Maximum age
21 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.