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NCT Number: NCT07568509

Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norethindrone Acetate-Ethinyl Estradiol

Drug

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

Other names: Estrogen-progestin

Primary outcomes

  1. 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

  1. Change in oxytocin from baseline

    Time frame: 0 minutes (Baseline) and 24 hours

    Change in oxytocin from baseline to 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Lamont, PhD

CONTACT

[email protected]

617-726-1347

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: Pedi-EVOLVE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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