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Testosterone Replacement Therapy in Chronic Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00266864
First received: December 15, 2005
Last updated: April 8, 2014
Last verified: April 2014

December 15, 2005
April 8, 2014
August 2003
August 2012   (final data collection date for primary outcome measure)
Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the "on-and-off -the-table" method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.
  •  muscular strength
  • To determine the effect of testosterone replacement therapy in hypogonadal males with SCI on:
  •  body composition, i.e. lean tissue and fat mass,
  •  glucose tolerance,
  •  resting energy expenditure
  •  autonomic-cardiovascular integrity
  •  psychological assessment
Complete list of historical versions of study NCT00266864 on ClinicalTrials.gov Archive Site
Resting Energy Expenditure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.
  • To determine differences between eugonadal and hypogonadal males with SCI in:
  •  body composition, i.e. lean tissue and fat mass,
  •  glucose tolerance,
  •  resting energy expenditure
  •  autonomic-cardiovascular integrity
  •  muscular strength
Not Provided
Not Provided
 
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Testosterone Replacement Therapy in Chronic Spinal Cord Injury

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

This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.

Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Hypogonadism
Drug: Testosterone Transdermal System (Androderm 5 mg patch)
Testosterone Transdermal System (Androderm 5 mg patch)
Other Name: Androgel (Testim) and Underarm Testosterone (Axiron)
  • Experimental: Testosterone Replacement Therapy
    Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
    Intervention: Drug: Testosterone Transdermal System (Androderm 5 mg patch)
  • Placebo Comparator: No Intervention
    Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266864
B2648-C
No
Department of Veterans Affairs
Department of Veterans Affairs
Kessler Institute for Rehabilitation
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP