Trial · NCT03345576

Testosterone and Long Pulse Stimulation After SCI

NCT03345576, Phase 2, Completed, VA Office of Research and Development; results first posted 2024-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testosterone and Long Pulse Stimulation After SCI. Trials, record NCT03345576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03345576

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Testosterone and Long Pulse Stimulation After SCI
NCT number: NCT03345576
Status: Completed
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Spinal Cord Injury
Interventions: Testosterone and LPWS, Testosterone and standard NMES
First posted: 2017-11-17
Last updated: 2025-10-14
Results first posted: 2024-12-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Muscle Size Change	Baseline, 6 months and 12 months	Magnetic resonance imaging (MRI): The skeletal muscle area will be measured at baseline 6 months and 12 months after training (post-intervention).
Secondary	Basal Metabolic Rate	Baseline, 6 months and 12 months	Using indirect canopy after overnight 10-12 hours fast.
Secondary	Mitochondrial Complex Activities	Mitochondrial measurements were conducted over 1 year period at baseline [BL, before starting any intervention], Post-intervention 1 [ P1; 6 months after starting interventions] and Post-intervention 2 [P2-12 months after starting interventions]	Performing a simple muscle biopsy and them muscle samples will be assayed to measure mitochondrial citrate synthase and other complexes.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Muscle Size Change	Baseline, 6 months and 12 months	We are reporting the results of magnetic resonance imaging analysis of the right whole thigh muscle cross-sectional area (CSA, cm\^2) and knee extensor CSA (CSA, cm\^2) at baseline, 6 months and 12 months of completion of Testosterone and LPWS or Testosterone and standard NMES.	Muscle CSA (cm^2)	MEAN
SECONDARY	Basal Metabolic Rate	Baseline, 6 months and 12 months	The numbers in P2 or at 12 months were different because of earlier withdrawal of participants from the study.	Basal Metabolic Rate (BMR; Kcal/day)	MEAN
SECONDARY	Mitochondrial Complex Activities	Mitochondrial measurements were conducted over 1 year period at baseline [BL, before starting any intervention], Post-intervention 1 [ P1; 6 months after starting interventions] and Post-intervention 2 [P2-12 months after starting interventions]	Three participants withdrew from Testosterone and LPWS before P2 as well as two participants withdrew from testosterone and standard NMES group before conducting P2.	nmol/min/mg	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Muscle Size Change	Testosterone and LPWS	Thigh Muscle CSA-BL (cm^2)	47.76	Standard Deviation 12.76	Muscle CSA (cm^2)
Muscle Size Change	Testosterone and Standard NMES	Thigh Muscle CSA-BL (cm^2)	31.1	Standard Deviation 12.65	Muscle CSA (cm^2)
Muscle Size Change	Testosterone and LPWS	Whole Thigh Muscle CSA (cm^2) 6 months	52.4	Standard Deviation 16.7	Muscle CSA (cm^2)
Muscle Size Change	Testosterone and Standard NMES	Whole Thigh Muscle CSA (cm^2) 6 months	36.0	Standard Deviation 9.96	Muscle CSA (cm^2)
Muscle Size Change	Testosterone and LPWS	Whole Thigh Muscle CSA (cm^2) 12 months	42.87	Standard Deviation 22.4	Muscle CSA (cm^2)
Muscle Size Change	Testosterone and Standard NMES	Whole Thigh Muscle CSA (cm^2) 12 months	41.1	Standard Deviation 12.6	Muscle CSA (cm^2)
Basal Metabolic Rate	Testosterone and LPWS	BMR-BL	1634	Standard Deviation 416	Basal Metabolic Rate (BMR; Kcal/day)
Basal Metabolic Rate	Testosterone and Standard NMES	BMR-BL	1580	Standard Deviation 383	Basal Metabolic Rate (BMR; Kcal/day)
Basal Metabolic Rate	Testosterone and LPWS	BMR- 6 Months	1564	Standard Deviation 428	Basal Metabolic Rate (BMR; Kcal/day)
Basal Metabolic Rate	Testosterone and Standard NMES	BMR- 6 Months	1424	Standard Deviation 250	Basal Metabolic Rate (BMR; Kcal/day)

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Testosterone and LPWS	6
Overall Study	STARTED	Testosterone and Standard NMES	6
Overall Study	COMPLETED	Testosterone and LPWS	3
Overall Study	COMPLETED	Testosterone and Standard NMES	4
Overall Study	NOT COMPLETED	Testosterone and LPWS	3
Overall Study	NOT COMPLETED	Testosterone and Standard NMES	2

Source ClinicalTrials.gov

Adverse events4

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 irritations as result of using testosterone patches	Skin and subcutaneous tissue disorders	Testosterone and LPWS	1	6	1
other	Skin irritations as result of using testosterone patches	Skin and subcutaneous tissue disorders	Testosterone and Standard NMES	0	6	0
serious	Cellulitis	Skin and subcutaneous tissue disorders	Testosterone and LPWS	2	6	2
serious	Cellulitis	Skin and subcutaneous tissue disorders	Testosterone and Standard NMES	0	6	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Testosterone and LPWS	0	6
Total, all-cause mortality	Testosterone and Standard NMES	0	6
Total, other adverse events	Testosterone and LPWS	1	6
Total, other adverse events	Testosterone and Standard NMES	0	6
Total, serious adverse events	Testosterone and LPWS	2	6
Total, serious adverse events	Testosterone and Standard NMES	0	6

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36198461	BACKGROUND	PubMed
36899099	RESULT	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Testosterone and LPWS vs Testosterone and Standard NMES: deaths from any cause	Trial comparisons
Testosterone and LPWS vs Testosterone and Standard NMES: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03345576

GET https://conductscience.org/api/trials/v1/NCT03345576/registered

API reference For AI assistants