An Early Phase 1 interventional study of Norethindrone Acetate-Ethinyl Estradiol in Arginine Vasopressin Deficiency and Oxytocin Deficiency, sponsored by Elizabeth Austen Lawson. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Elizabeth Austen Lawson · Early Phase 1, Interventional, and Diagnostic
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:
27 studies on the registry are indexed under Diabetes Insipidus, Neurogenic; 12 are open to participants now.
This study's enrollment of 28 is below the median of 42 across 23 interventional studies indexed under Diabetes Insipidus, Neurogenic.
Browse Diabetes Insipidus, Neurogenic studies →Elizabeth Austen Lawson is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
Exclusion Criteria for all participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency
Drug: Norethindrone Acetate-Ethinyl Estradiol
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.
Drug: Norethindrone Acetate-Ethinyl Estradiol
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
Also known as: Estrogen-progestin
Change in peripheral oxytocin concentration from 0 to 24 hours
Change in peripheral oxytocin concentration from 0 to 24 hours
Time frame: Time points: time 0 min (baseline) and 24 hours
Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls
Difference from baseline to oxytocin peak (blood and saliva) between patients with arginine-vasopressin deficiency compared to healthy controls. Correlation between oxytocin area under the curve and psychopathology and quality of life measures across groups.
Time frame: From time 0 min (baseline) to 48 hours
Plan to share: No
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Diabetes Insipidus, Neurogenic →
Elizabeth Austen Lawson