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โ† Trials
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Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

RecruitingEARLY Phase 1Ages 7 Years - 21 YearsAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ€ข 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.
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What it tests

  • Norethindrone Acetate-Ethinyl Estradiol
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Where

1 site
Massachusetts General Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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