Phase 3
N=31
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Spinal Cord Injury · Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT00266864 ↗Enrolled (actual)
31
Serious AEs
5.6%
Results posted
Apr 2014
Primary outcome: Primary: Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) — 53.1; 50.5 kilograms — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone Transdermal System (Androderm 5 mg patch) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) |
53.1; 50.5 | <0.01 sig |
| SECONDARY Resting Energy Expenditure |
1440; 1339 | 0.051 |
Summary
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
Eligibility Criteria
Inclusion Criteria
- Males 18-49 years of age
- Chronic spinal cord injury
- Normal prostate specific antigen levels and digital rectal exam
- No known cardiovascular disease
- Subjects with total testosterone > 4 ng/ml
- Subjects with total testosterone > 4 ng/ml
Exclusion Criteria
- Females
- Known coronary heart and/or artery disease, diabetes mellitus
- Previous or current cancer
- Current or previous anabolic steroid use
- Acute inter-current illness
- Abnormal liver function test (>1.5 times normal values) at baseline
- Prostate specific antigen above normal
- Abnormal digital rectal exam at baseline suggestive of malignancy
- Current alcohol or drug abuse
- Significant psychological disorders
Data sourced from ClinicalTrials.gov (NCT00266864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.