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NCT07557615 · ClinicalTrials.gov registry record · Early Phase 1
hCG Treatment for Rehabilitation From a TBI
A Early Phase 1 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT07557615: Clinical Trial Early Phase 1 study, sponsored by VA Office of Research and Development.
NCT07557615 is a Early Phase 1 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07557615, a Early Phase 1 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The COGNI-REHAB Trial is a single-site, phase O/I, randomized, double-blind, placebo-controlled study of human chorionic gonadotropin (hCG; choriogonadotropin alfa, Ovidrel®) in men with post-acute, moderate to severe traumatic brain injury (msTBI). Its objective is to assess the safety and efficacy of a 24-week regimen of Ovidrel (125 micrograms twice weekly) compared to placebo on treatment-emergent adverse events (TEAEs), cognitive and functional recovery, and circulating sex hormones.
Primary Outcome
The frequency and type of individual TEAEs, discontinuations due to TEAEs, serious TEAEs, and clinically significant changes in laboratory test values.
Interventions
- OTHER Placebo
- DRUG Ovidrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2029-09-30 |
| Phase | Early Phase 1 |
What is known before NCT07557615 opens enrollment
NCT07557615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07557615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07557615 about?
NCT07557615 is a clinical study titled "hCG Treatment for Rehabilitation From a TBI". The COGNI-REHAB Trial is a single-site, phase O/I, randomized, double-blind, placebo-controlled study of human chorionic gonadotropin (hCG; choriogonadotropin alfa, Ovidrel®) in men with post-acute, moderate to severe traumatic brain injury (msTBI). Its objective is to assess the safety and efficacy...
What is the current status of trial NCT07557615?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2026-10-01. Estimated completion is 2029-09-30.
What interventions are being tested in trial NCT07557615?
The interventions under investigation include: Placebo (OTHER), Ovidrel (DRUG).
Who is sponsoring clinical trial NCT07557615?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07557615's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,467 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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