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NCT07568509 · ClinicalTrials.gov registry record · Early Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT07568509: Recruiting Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT07568509 is a Early Phase 1 study that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07568509, a Early Phase 1 study, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
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.
Primary Outcome
Change in neurophysin-1 levels from baseline to 24 hours
Interventions
- DRUG Norethindrone Acetate-Ethinyl Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-05 |
| Est. Completion | 2027-04 |
| Phase | Early Phase 1 |
What NCT07568509 shows while recruiting
NCT07568509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Norethindrone Acetate-Ethinyl Estradiol is the first listed.
NCT07568509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07568509 about?
NCT07568509 is a clinical study titled "Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease". 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 sti...
What is the current status of trial NCT07568509?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-05. Estimated completion is 2027-04.
What interventions are being tested in trial NCT07568509?
The interventions under investigation include: Norethindrone Acetate-Ethinyl Estradiol (DRUG).
Who is sponsoring clinical trial NCT07568509?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07568509's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 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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