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NCT06460948 · ClinicalTrials.gov registry record · Early Phase 1
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
A Early Phase 1 study of Arginine Vasopressin Deficiency and Oxytocin Deficiency, sponsored by Elizabeth Austen Lawson.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06460948: Recruiting Early Phase 1 study of Arginine Vasopressin Deficiency and Oxytocin Deficiency, sponsored by Elizabeth Austen Lawson.
NCT06460948 is a Early Phase 1 study of Arginine Vasopressin Deficiency and Oxytocin Deficiency that is actively recruiting participants, run by Elizabeth Austen Lawson. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06460948, a Early Phase 1 study of Arginine Vasopressin Deficiency and Oxytocin Deficiency, is actively recruiting participants, sponsored by Elizabeth Austen Lawson.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
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: 1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control. 2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
Primary Outcome
Change in peripheral oxytocin concentration from 0 to 24 hours
Conditions Studied
Interventions
- DRUG Norethindrone Acetate-Ethinyl Estradiol
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2026-06 |
| Phase | Early Phase 1 |
What NCT06460948 shows while recruiting
NCT06460948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Arginine Vasopressin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Norethindrone Acetate-Ethinyl Estradiol is the first listed.
NCT06460948 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06460948 about?
NCT06460948 is a clinical study titled "Identifying Oxytocin Deficiency in Adults With Pituitary Disease". 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 ...
What is the current status of trial NCT06460948?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2024-11-13. Estimated completion is 2026-06.
What conditions does trial NCT06460948 study?
This clinical trial studies the following conditions: Arginine Vasopressin Deficiency, Oxytocin Deficiency.
What interventions are being tested in trial NCT06460948?
The interventions under investigation include: Norethindrone Acetate-Ethinyl Estradiol (DRUG).
Who is sponsoring clinical trial NCT06460948?
This trial is sponsored by Elizabeth Austen Lawson, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06460948 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06460948's enrollment target sits among peer trials
32 775th of 2000 higher than 1,208 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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