Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT07568509
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.
Interested in participating?
Request Info7 year–21 year
All sexes
Interventional
Early Phase 1
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(participants with AVP-D):
Inclusion criteria
(participants with hypopituitary disease):
Exclusion criteria
(all participants):
Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
Other names: Estrogen-progestin
Time frame: 0 minutes (Baseline) and 24 hours
Change in neurophysin-1 levels from baseline to 24 hours
Time frame: 0 minutes (Baseline) and 24 hours
Change in oxytocin from baseline to 24 hours
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism
Acronym: Pedi-EVOLVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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