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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Norethindrone Acetate-Ethinyl Estradiol
DrugNorethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D).Experimental treatment 1 intervention
Group B: Individuals with hypopituitary disease (without AVP-D)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in neurophysin-1 from baseline
Change in neurophysin-1 levels from baseline to 24 hours
Time frame
0 minutes (Baseline) and 24 hoursSecondary outcomes
1
Change in oxytocin from baseline
Change in oxytocin from baseline to 24 hours
Time frame
0 minutes (Baseline) and 24 hoursSponsors and contacts
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Source ClinicalTrials.gov