Trial · NCT00266864
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
NCT00266864, Phase 2, Phase 3, Completed, VA Office of Research and Development; results first posted 2014-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testosterone Replacement Therapy in Chronic Spinal Cord Injury. Trials, record NCT00266864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00266864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testosterone Replacement Therapy in Chronic Spinal Cord Injury
- NCT number
- NCT00266864
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Spinal Cord Injury, Hypogonadism
- Interventions
- Testosterone Transdermal System (Androderm 5 mg patch)
- First posted
- 2005-12-19
- Last updated
- 2017-11-01
- Results first posted
- 2014-04-07
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | 12 months | 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. |
| Secondary | Resting Energy Expenditure | 12 months | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | 12 months | kilograms | MEAN | |
| SECONDARY | Resting Energy Expenditure | 12 months | kcal/day | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | Testosterone Replacement Therapy | 53.1 | Standard Deviation 6.9 | kilograms | |
| Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | No Intervention | 50.5 | Standard Deviation 6.3 | kilograms | |
| Resting Energy Expenditure | Testosterone Replacement Therapy | 1440 | Standard Deviation 262 | kcal/day | |
| Resting Energy Expenditure | No Intervention | 1339 | Standard Deviation 128 | kcal/day |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testosterone Replacement Therapy | 18 | |
| Overall Study | STARTED | No Intervention | 13 | |
| Overall Study | COMPLETED | Testosterone Replacement Therapy | 13 | |
| Overall Study | COMPLETED | No Intervention | 11 | |
| Overall Study | NOT COMPLETED | Testosterone Replacement Therapy | 5 | |
| Overall Study | NOT COMPLETED | No Intervention | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin irritation | Skin and subcutaneous tissue disorders | Testosterone Replacement Therapy | 11 | 18 | 11 |
| other | Acne | Skin and subcutaneous tissue disorders | Testosterone Replacement Therapy | 1 | 18 | 1 |
| other | Edema | Blood and lymphatic system disorders | Testosterone Replacement Therapy | 4 | 18 | 4 |
| other | Elevated hemoglobin and hematocrit | Blood and lymphatic system disorders | Testosterone Replacement Therapy | 1 | 18 | 1 |
| other | Liver function enzymes | Hepatobiliary disorders | Testosterone Replacement Therapy | 1 | 18 | 1 |
| serious | Urinary tract infection | Renal and urinary disorders | Testosterone Replacement Therapy | 1 | 18 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testosterone Replacement Therapy | ||
| Total, other adverse events | Testosterone Replacement Therapy | 11 | 18 |
| Total, serious adverse events | Testosterone Replacement Therapy | 1 | 18 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00266864
GET https://conductscience.org/api/trials/v1/NCT00266864/registered