Clinical Trial

hCG Treatment for Rehabilitation From a TBI

Study acronym: COGNI-REHAB
Not Yet Recruiting Early Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-22.
Trial Details
NCT Number NCT07557615
Lead Sponsor VA Office of Research and Development
Conditions Traumatic Brain Injury
Enrollment 50 participants
Start Date 2026-10-01
Primary Completion 2029-07-01 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-06