Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease (Pedi-EVOLVE)

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.