Trial · NCT02248701
Testosterone Plus Finasteride Treatment After Spinal Cord Injury
NCT02248701, Phase 2, Terminated, VA Office of Research and Development; results first posted 2023-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testosterone Plus Finasteride Treatment After Spinal Cord Injury. Trials, record NCT02248701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02248701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testosterone Plus Finasteride Treatment After Spinal Cord Injury
- NCT number
- NCT02248701
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male
- Interventions
- Testosterone Enanthate, Finasteride, Placebo injection, Placebo pill
- First posted
- 2014-09-25
- Last updated
- 2023-09-29
- Results first posted
- 2023-09-29
- Limitations and caveats
This trial was terminated early due to enrollment and retention difficulties that persisted during the severe acute respiratory syndrome (SARS)-Cov19 pandemic. This resulted in a smaller number of subjects being enrolled and undergoing testing than was originally planned in our a priori analysis.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Hip Bone Mineral Density | Baseline, 6 months, 12 months | Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA) |
| Primary | Percent Changes in Muscle Cross-Sectional Area | Baseline, 6 months, 12 months | Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI |
| Primary | Percent Change in Total Body Fat | Baseline, 6 months, 12 months | Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA) |
| Primary | Absolute Change in Walking Speed | Baseline, 6 months, 12 months | Absolute change in 10 m walking speed |
| Secondary | Percent Change in Neuromuscular Function | Baseline, 6 months, 12 months | Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry |
| Secondary | Percent Change in Visceral Fat | Baseline, 6 months, 12 months | Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Hip Bone Mineral Density | Baseline, 6 months, 12 months | Only 5 participants in the testosterone enanthate group were evaluated because 1 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group and 2 additional participants in the testosterone enanthate group had withdrawn from the study and data from 1 participant in the testosterone enanthate group could not be analyzed due to imaging artefact. | percent change | MEAN |
| PRIMARY | Percent Changes in Muscle Cross-Sectional Area | Baseline, 6 months, 12 months | Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. Only 4 participants in the placebo group were evaluated because 1 of 5 with baseline values did not have a follow-up MRI. At 12 months: 1 participant in the placebo group and 2 additional participants in the testosterone enanthate group had withdrawn from the study. | percent change | MEAN |
| PRIMARY | Percent Change in Total Body Fat | Baseline, 6 months, 12 months | Only 4 participants in the testosterone enanthate group were evaluated because 2 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participants in the testosterone enanthate group had withdrawn from the study. | percent change | MEAN |
| PRIMARY | Absolute Change in Walking Speed | Baseline, 6 months, 12 months | Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants had withdrawn from the placebo group and an additional 2 participants had withdrawn from the testosterone enanthate group. | meters/second (m/s) change | MEAN |
| SECONDARY | Percent Change in Neuromuscular Function | Baseline, 6 months, 12 months | Only 5 participants in the testosterone enanthate group were evaluated because 2 of 7 with baseline values had withdrawn prior to 6 months. At 6 months: 1 participant in the placebo group and 1 participant in the testosterone enanthate group did not perform testing. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participant in the testosterone enanthate group had withdrawn from the study. | percent change | MEAN |
| SECONDARY | Percent Change in Visceral Fat | Baseline, 6 months, 12 months | Only 4 participants in the testosterone enanthate group were evaluated because 2 of 6 with baseline values had withdrawn prior to 6 months. At 12 months: 2 participants in the placebo group had withdrawn from the study and 2 additional participants in the testosterone enanthate group had withdrawn from the study. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Hip Bone Mineral Density | Testosterone Enanthate, Finasteride | Change at 6 months | 1.7 | Standard Deviation 4.7 | percent change |
| Percent Change in Hip Bone Mineral Density | Placebo Treatment | Change at 6 months | -0.5 | Standard Deviation 2.4 | percent change |
| Percent Change in Hip Bone Mineral Density | Testosterone Enanthate, Finasteride | Change at 12 months | 1.2 | Standard Deviation 7.3 | percent change |
| Percent Change in Hip Bone Mineral Density | Placebo Treatment | Change at 12 months | 1.1 | Standard Deviation 4.9 | percent change |
| Percent Changes in Muscle Cross-Sectional Area | Testosterone Enanthate, Finasteride | 6 months | 7.9 | Standard Deviation 4.4 | percent change |
| Percent Changes in Muscle Cross-Sectional Area | Placebo Treatment | 6 months | -0.9 | Standard Deviation 4.1 | percent change |
| Percent Changes in Muscle Cross-Sectional Area | Testosterone Enanthate, Finasteride | 12 months | 11.4 | Standard Deviation 6.0 | percent change |
| Percent Changes in Muscle Cross-Sectional Area | Placebo Treatment | 12 months | -1.9 | Standard Deviation 4.3 | percent change |
| Percent Change in Total Body Fat | Testosterone Enanthate, Finasteride | 6 months | -6.8 | Standard Deviation 5.0 | percent change |
| Percent Change in Total Body Fat | Placebo Treatment | 6 months | -4.7 | Standard Deviation 10.6 | percent change |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testosterone Enanthate, Finasteride | 7 | |
| Overall Study | STARTED | Placebo Treatment | 5 | |
| Overall Study | COMPLETED | Testosterone Enanthate, Finasteride | 3 | |
| Overall Study | COMPLETED | Placebo Treatment | 3 | |
| Overall Study | NOT COMPLETED | Testosterone Enanthate, Finasteride | 4 | |
| Overall Study | NOT COMPLETED | Placebo Treatment | 2 |
Source ClinicalTrials.gov
Adverse events140
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 | aldolase, high | General disorders | Testosterone Enanthate, Finasteride | 1 | 7 | 1 |
| other | aldolase, high | General disorders | Placebo Treatment | 0 | 5 | 0 |
| other | anion gap, high | General disorders | Testosterone Enanthate, Finasteride | 1 | 7 | 1 |
| other | anion gap, high | General disorders | Placebo Treatment | 2 | 5 | 3 |
| other | alanine aminotransferase (ALT), high | Investigations | Testosterone Enanthate, Finasteride | 2 | 7 | 2 |
| other | alanine aminotransferase (ALT), high | Investigations | Placebo Treatment | 1 | 5 | 1 |
| other | aspartate aminotransferase (AST), high | Investigations | Testosterone Enanthate, Finasteride | 1 | 7 | 1 |
| other | aspartate aminotransferase (AST), high | Investigations | Placebo Treatment | 0 | 5 | 0 |
| other | albumin, high | General disorders | Testosterone Enanthate, Finasteride | 0 | 7 | 0 |
| other | albumin, high | General disorders | Placebo Treatment | 1 | 5 | 1 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testosterone Enanthate, Finasteride | 0 | 7 |
| Total, all-cause mortality | Placebo Treatment | 0 | 5 |
| Total, other adverse events | Testosterone Enanthate, Finasteride | 7 | 7 |
| Total, other adverse events | Placebo Treatment | 5 | 5 |
| Total, serious adverse events | Testosterone Enanthate, Finasteride | 1 | 7 |
| Total, serious adverse events | Placebo Treatment | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39722695 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| I01RX001449 | Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI | YARROW, JOSHUA F. | VETERANS HEALTH ADMINISTRATION | Veterans Affairs | 2015 to 2021 | NIH RePORTER |
| IK1RX002327 | Testosterone Plus Finasteride Therapy to Improve Walking Function After SCI | OTZEL, DANA M | VETERANS HEALTH ADMINISTRATION | Veterans Affairs | 2017 to 2018 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Testosterone Enanthate, Finasteride vs Placebo Treatment: deaths from any cause | Trial comparisons |
| Testosterone Enanthate, Finasteride vs Placebo Treatment: serious adverse events | Trial comparisons |
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/NCT02248701
GET https://conductscience.org/api/trials/v1/NCT02248701/results?page=2