DRUG
Norethindrone Acetate-Ethinyl Estradiol
Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
Status
Recruiting
Phase
Early Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
Timeline
First posted
May 5, 2026
Study start
Aug 2026
Primary completion
Apr 2027
Study completion
Apr 2027
Results posted
Not reported
Registry updated
Jul 23, 2026
Outcomes
Change in neurophysin-1 from baseline
Time frame · 0 minutes (Baseline) and 24 hours
Change in neurophysin-1 levels from baseline to 24 hours
Change in oxytocin from baseline
Time frame · 0 minutes (Baseline) and 24 hours
Change in oxytocin from baseline to 24 hours
Eligibility
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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