Last reviewed · How we verify
Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Phase 2 trial testing Testosterone Enanthate in Spinal Cord Injury in 33 participants. Terminated before completion.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 33 |
| Start date | 27 April 2017 |
| Primary completion | 13 August 2021 |
| Estimated completion | 13 August 2021 |
| Sites | 2 locations across United States |
VA Office of Research and Development — full company profile →
18 and older, male only, with Spinal Cord Injury or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 1.7 | ± 4.7 |
| Placebo Treatment | -0.5 | ± 2.4 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 1.2 | ± 7.3 |
| Placebo Treatment | 1.1 | ± 4.9 |
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 7.9 | ± 4.4 |
| Placebo Treatment | -0.9 | ± 4.1 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 11.4 | ± 6.0 |
| Placebo Treatment | -1.9 | ± 4.3 |
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | -6.8 | ± 5.0 |
| Placebo Treatment | -4.7 | ± 10.6 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | -8.7 | ± 8.4 |
| Placebo Treatment | -1.9 | ± 9.1 |
Absolute change in 10 m walking speed
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 0 | ± 0.17 |
| Placebo Treatment | 0.05 | ± 0.14 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 0.10 | ± 0.12 |
| Placebo Treatment | 0.01 | ± 0.15 |
Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 19.9 | ± 30.7 |
| Placebo Treatment | -8.6 | ± 14.9 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | 15.5 | ± 27.0 |
| Placebo Treatment | 0.5 | ± 35.1 |
Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | -8.2 | ± 17.0 |
| Placebo Treatment | -3.2 | ± 7.7 |
| Group | Value | 95% CI |
|---|---|---|
| Testosterone Enanthate, Finasteride | -13.6 | ± 9.4 |
| Placebo Treatment | 0.2 | ± 11.6 |
Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Testosterone Enanthate, Fi… | Placebo Treatment |
|---|---|---|---|
| Hospitalization | Infections and infestations | — | — |
| Reaction | System | Testosterone Enanthate, Fi… | Placebo Treatment |
|---|---|---|---|
| estradiol, high | Investigations | — | — |
| glucose, high | Investigations | — | — |
| monocytes, high | General disorders | — | — |
| C-reactive protein (CRP), high | General disorders | — | — |
| dihydrotestosterone, low | Investigations | — | — |
| eosinophils, high | General disorders | — | — |
| HDL cholesterol, low | Investigations | — | — |
| testosterone, high | Investigations | — | — |
| total cholesterol, high | Investigations | — | — |
| granulocytes, high | General disorders | — | — |
| granulocytes, low | General disorders | — | — |
| insulin, high | Investigations | — | — |
| lymphocytes, low | General disorders | — | — |
| mean platelet volume, high | General disorders | — | — |
| triglycerides, high | Investigations | — | — |
| falls | Musculoskeletal and connective tissue disorders | — | — |
| hematocrit, low | Investigations | — | — |
| hemoglobin, low | Investigations | — | — |
| LDL cholesterol, high | Investigations | — | — |
| lymphocytes, high | General disorders | — | — |
| mean corpuscular hemoglobin concentration, low | General disorders | — | — |
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| red blood cell count, low | General disorders | — | — |
| red blood cell distribution width, high | General disorders | — | — |
| anion gap, high | General disorders | — | — |
| alanine aminotransferase (ALT), high | Investigations | — | — |
| CO2, low | General disorders | — | — |
| creatinine, high | General disorders | — | — |
| erythropoietin, high | General disorders | — | — |
| potassium, low | General disorders | — | — |
| mean corpuscular hemoglobin, low | General disorders | — | — |
| prostate-specific antigen (PSA), high | Investigations | — | — |
| red blood cell distribution width, low | General disorders | — | — |
| testosterone, low | Investigations | — | — |
| urea nitrogen, high | General disorders | — | — |
| urea nitrogen, low | General disorders | — | — |
| aldolase, high | General disorders | — | — |
| aspartate aminotransferase (AST), high | Investigations | — | — |
| albumin, high | General disorders | — | — |
| alkaline phosphatase, high | General disorders | — | — |
Most-reported serious reactions: Hospitalization.
Data from ClinicalTrials.gov NCT02248701 adverse events section.
The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.
2 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02248701.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing