Testosterone Replacement Therapy in Chronic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266864
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : April 7, 2014
Last Update Posted : November 1, 2017
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Spinal Cord Injury
Intervention: Drug: Testosterone Transdermal System (Androderm 5 mg patch)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Testosterone Replacement Therapy Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
No Intervention Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.

Participant Flow:   Overall Study
    Testosterone Replacement Therapy   No Intervention
STARTED   18   13 
COMPLETED   13   11 
Lost to Follow-up                4                1 
Withdrawal by Subject                1                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Testosterone Replacement Therapy Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
No Intervention Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
Total Total of all reporting groups

Baseline Measures
   Testosterone Replacement Therapy   No Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   11   24 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      11 100.0%      24 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex/Gender, Customized [1] 
[Units: Participants]
Male   13   11   24 
[1] Hypogonadal (Testosterone Replacement Therapy group, total testosterone < 4 ng/ml) and Eugonadal (No Intervention group total testosterone > 4 ng/ml) subjects
Region of Enrollment 
[Units: Participants]
United States   13   11   24 
Dual energy x-ray absorptiometry (DXA) for lean tissue mass [1] 
[Units: Kilograms]
Mean (Standard Deviation)
 49.6  (7.6)   51.9  (8.1)   50.8  (7.8) 
[1] Body composition measurements for measures of total body lean tissue mass (LTM) were assessed by dual energy X-ray absorptiometry (DXA; General Electric LUNAR Prodigy Advance, software version 11.4 and 12.2, Madison, WI). 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.
Resting Energy Expenditure [1] 
[Units: Kcal/day]
Mean (Standard Deviation)
 1328  (262)   1319  (112)   1324  (197) 
[1] 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 and was adjusted to account for differences in total body lean tissue mass. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12 hour fast, with a minimum of 24 hours free from any type of exercise.

  Outcome Measures

1.  Primary:   Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)   [ Time Frame: 12 months ]

2.  Secondary:   Resting Energy Expenditure   [ Time Frame: 12 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Compared to similar trials our trial was relatively small. Although there was statistical and clinical changes associated with testosterone replacement therapy, the translation of these findings with regard to functional gain was not addressed.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: William A. Bauman, M.D.
Organization: James J. Peters VA Medical Center
phone: 718-584-9000 ext 5428

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: VA Office of Research and Development Identifier: NCT00266864     History of Changes
Other Study ID Numbers: B2648-C
First Submitted: December 15, 2005
First Posted: December 19, 2005
Results First Submitted: December 19, 2013
Results First Posted: April 7, 2014
Last Update Posted: November 1, 2017