Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age7-21
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Norethindrone Acetate-Ethinyl Estradiol
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov