Checking oxytocin levels in children with pituitary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, transient ischemic attack, 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.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.