Head Injury and Testosterone

A 12-month, double-blind, randomised, placebo-controlled clinical trial to determine the efficacy of multiple-dose testosterone undecanoate administration on neuropsychological, psychosocial and biological markers (biomarkers) in male participants with traumatic brain injury.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001219774

Acronym

HIT Study

Enrollment

Registered

2013-11-06

Start date

2014-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to investigate whether testosterone injections with initial administration within three months of traumatic brain injury (TBI) can assist in recovery from brain injury and reduce the risk for the development of Alzheimer’s Disease (AD) related biomarkers.

Interventions

Participants will receive either testosterone undecanoate intramuscular injection (REANDRON 'Registered Trademark' 1000mg/4ml solution) or placebo at 8-week intervals for 48-weeks, with initial administration occurring within 3-months of traumatic brain injury. Ampoules of REANDRON 'Registered Trademark' and matching placebo will be supplied by Bayer-Schering, Australia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

Male; Aged 20 to 65 years old; Brain injured with a severity of moderate to severe on admission Glasgow Coma Scale (GCS score of 7 to 12); Able to personally read and understand the Participant Information and Consent Form, and provide written, signed and dated informed consent to participate in study; Having been discharged from acute-care hospital stay and able to receive an initial injection within 3 months of injury; Able and willing to meet all protocol-required procedures and visits.

Exclusion criteria

Previous or ongoing chronic or recurrent disease of the central nervous system or psychiatric disease that may have an impact on cognitive performance (e.g. Bipolar disorder, Dementia, Schizophrenia, Parkinson’s disease etc.). This also includes drug/alcohol dependency related disorders; People whose primary language is other than English; Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function; Treatment with testosterone replacement therapy during the last five years; Known history of prostate cancer, abnormal prostate evidenced by prostate examination, elevated levels of prostate specific antigen (PSA) (>4ng/mL) for participants age 50 years old and over; Uncontrolled hypertension, diabetes mellitus, renal disease (eGFR <50 mL/min), cardiac disease, haematological disease, liver or lung disease; Systolic Blood Pressure >170mmHg and Diastolic Blood Pressure >100mmHg

Outcome results