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RecruitingNCT07568509Pedi-EVOLVEUpdated Oct 26, 2026

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

An Early Phase 1 interventional study of Norethindrone Acetate-Ethinyl Estradiol in Arginine Vasopressin Deficiency, Oxytocin Deficiency and Pediatric Disease, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 7 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 26, 2026Eligibility revisedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
7 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arginine Vasopressin Deficiency
  • Oxytocin Deficiency
  • Pediatric Disease
  • Hypopituitarism
03

In context

Diabetes Insipidus, Neurogenic

27 studies on the registry are indexed under Diabetes Insipidus, Neurogenic; 12 are open to participants now.

This study's planned enrollment of 20 is below the median of 42 across 23 interventional studies indexed under Diabetes Insipidus, Neurogenic.

Browse Diabetes Insipidus, Neurogenic studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Browse Massachusetts General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
7 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria, participants with AVP-D:

  • AVP-D diagnosis
  • Age 7 to 21 years
  • Stable pituitary hormone replacement (no change in dose of hormone replacement in 4 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

Inclusion criteria, PD:

  • Pituitary disease diagnosis
  • Age 7 to 21 years
  • Eligible participants are not required to be on hormone replacement for pituitary deficiencies. If receiving pituitary hormone replacement, no change in dose in 4 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 for participants with PD

  • Current AVP-D diagnosis or desmopressin use

Exclusion criteria for 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 ischemic stroke, , myocardial infarction, angina pectoris, or peripheral arterial disease
  • Pregnancy or breastfeeding within the last 8 weeks
  • History of stage 3 chronic kidney disease or cirrhosis
  • Active tobacco smoking or nicotine use
  • Psychosis or active suicidality
  • Known genetic cause of vasopressin deficiency.
  • Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Drug: Norethindrone Acetate-Ethinyl Estradiol

  • Experimental
    Individuals with hypopituitary disease (without AVP-D)

    Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects.

    Drug: Norethindrone Acetate-Ethinyl Estradiol

Interventions

  • DrugNorethindrone Acetate-Ethinyl Estradiol

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

    Also known as: Estrogen-progestin

06

What researchers measure

Primary outcomes

  1. Change in neurophysin-1 from baseline

    Change in neurophysin-1 levels from baseline to 24 hours

    Time frame: 0 minutes (Baseline) and 24 hours

Secondary outcomes

  1. Change in oxytocin from baseline

    Change in oxytocin from baseline to 24 hours

    Time frame: 0 minutes (Baseline) and 24 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 5, 2026
StartActual
Aug 17, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion removed; 1 exclusion criterion removed; 7 criteria edited, 8 added
What changed in the criteria
  • EditedInclusion criteria (, participants with hypopituitary disease)AVP-D:
  • AddedAVP-D diagnosis
  • AddedAge 7 to 21 years
  • EditedStable pituitary hormone replacement (no change in dose of hormone replacement in six4 weeks prior to baseline);
  • AddedInclusion criteria, PD:
  • EditedHypopituitaryPituitary disease diagnosis;
  • AddedAge 7 to 21 years
  • EditedEligible participants are not required to be on hormone replacement for pituitary deficiencies. If receiving pituitary hormone replacement, no change in dose in six4 weeks prior to baseline);
  • EditedIf on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits;
  • AddedExclusion criteria for participants with PD
  • AddedCurrent AVP-D diagnosis or desmopressin use
  • AddedExclusion criteria for all participants:
  • EditedHistory of ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;
  • EditedActive tobacco smoking or nicotine patch use;
  • AddedKnown genetic cause of vasopressin deficiency.
Inclusion criteria
  • RemovedAVP-D diagnosed in clinic using standard of care diagnostic tools;
Exclusion criteria
  • RemovedMedication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Eligibility 1 inclusion criterion removed; 1 exclusion criterion removed; 7 criteria edited, 8 added
    What changed in the criteria
    • EditedInclusion criteria (, participants with hypopituitary disease)AVP-D:
    • AddedAVP-D diagnosis
    • AddedAge 7 to 21 years
    • EditedStable pituitary hormone replacement (no change in dose of hormone replacement in six4 weeks prior to baseline);
    • AddedInclusion criteria, PD:
    • EditedHypopituitaryPituitary disease diagnosis;
    • AddedAge 7 to 21 years
    • EditedEligible participants are not required to be on hormone replacement for pituitary deficiencies. If receiving pituitary hormone replacement, no change in dose in six4 weeks prior to baseline);
    • EditedIf on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits;
    • AddedExclusion criteria for participants with PD
    • AddedCurrent AVP-D diagnosis or desmopressin use
    • AddedExclusion criteria for all participants:
    • EditedHistory of ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;
    • EditedActive tobacco smoking or nicotine patch use;
    • AddedKnown genetic cause of vasopressin deficiency.
    Inclusion criteria
    • RemovedAVP-D diagnosed in clinic using standard of care diagnostic tools;
    Exclusion criteria
    • RemovedMedication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07568509
Lead sponsor
Massachusetts General Hospital
Responsible party
Elizabeth Austen Lawson (Associate Professor of Medicine, Massachusetts General Hospital) — Principal investigator
First posted
May 5, 2026
Start date
Aug 17, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Hannah Lamont, PhD
Contact
MGHHypopit@MGH.HARVARD.EDU
617-726-1347
Elizabeth A Lawson, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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