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.

The McCusker Alzheimer's Research Foundation0 个研究点目标入组 80 人开始时间: 2013年11月6日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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

发起方

The McCusker Alzheimer's Research Foundation