Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease

Официальное название

Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism

Обзор

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.

Вмешательства

• Препарат Norethindrone Acetate-Ethinyl Estradiol
  Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.

Первичные конечные точки

• Change in neurophysin-1 from baseline [Срок оценки: 0 minutes (Baseline) and 24 hours]

Вторичные конечные точки (1)

• Change in oxytocin from baseline [Срок оценки: 0 minutes (Baseline) and 24 hours]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07568509 · 2025P001958

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗