Checking oxytocin levels in children with pituitary disease
Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism
This pilot will test whether a single oral dose of combined estrogen/progestin boosts oxytocin release in young people with pituitary-related hormone deficiencies and matched controls.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07568509 on ClinicalTrials.gov |
What this trial studies
This open-label, interventional pilot will recruit 10 youth with arginine vasopressin deficiency and 10 matched pediatric patients with hypopituitarism from Massachusetts General Hospital and the surrounding community. Eligible participants will receive two tablets (total 1 mg norethindrone acetate and 70 mcg ethinyl estradiol) and blood and saliva samples will be taken at baseline and about 24 hours after dosing to measure oxytocin release. Neuropsychological measures of mood, anxiety, impulse control, eating behavior, social cognition, and quality of life will be collected at baseline to characterize participants. Key enrollment requirements include stable pituitary hormone replacement for at least six weeks and stopping any estrogen/progestin use for six weeks prior to the main visits, and participants with histories of thrombosis or certain cancers are excluded.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients with diagnosed AVP deficiency or hypopituitarism who are on stable hormone replacement, can temporarily stop estrogen/progestin if applicable, and can attend in-person visits at the study site.
Not a fit: Patients with a history of blood clots, stroke, breast or endometrial cancer, current use of estrogen modulators or aromatase inhibitors, inability to stop estrogen/progestin, or who cannot attend the Boston site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reveal reversible oxytocin deficiency and guide hormone-based strategies to improve social, mood, or eating-related symptoms in affected youth.
How similar studies have performed: Hormonal provocation to stimulate oxytocin has been explored in adults, but this specific approach in pediatric pituitary populations is novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth A Lawson, MD — Massachusetts General Hospital
- Study coordinator: Hannah Lamont, PhD
- Email: MGHHypopit@MGH.HARVARD.EDU
- Phone: 617-726-1347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.