NCT07568509 Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
| NCT ID | NCT07568509 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Arginine Vasopressin Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-05 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Elizabeth A Lawson, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07568509 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 21 Years, studying Arginine Vasopressin Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07568509 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07568509 currently recruiting?
Yes, NCT07568509 is actively recruiting participants. Contact the research team at MGHHypopit@MGH.HARVARD.EDU for enrollment information.
Where is the NCT07568509 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07568509 clinical trial?
NCT07568509 is sponsored by Massachusetts General Hospital. The principal investigator is Elizabeth A Lawson, MD at Massachusetts General Hospital. The trial plans to enroll 20 participants.