Spinal Cord InjuryPhase 2NCT02248701

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

A Phase 2 study testing Testosterone Enanthate and Finasteride in people with Spinal Cord Injury and Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System
What is being tested?: Testosterone Enanthate and Finasteride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: 27 Apr 2017to 13 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male > 18 years of age
Traumatic, vascular, or orthopedic spinal cord injury between C2-L3 >12 months prior to enrollment
Motor incomplete spinal cord (AIS C/D)
Ambulatory dysfunction
Medically stable condition that is asymptomatic for bladder infection, decubiti, cardiopulmonary disease, or other significant medical conditions
Serum total testosterone (<325 ng/dL) or bioavailable testosterone (<70 ng/dL)

Who cannot join

Currently participating in another research protocol that may influence study outcomes
Life expectancy <1 year
History of or current congenital spinal cord injury or other degenerative spinal disorder
Diagnosis of multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment/injury
History of venous thromboembolism within the last 6 months, specifically deep venous thromboembolism and pulmonary embolism, history of recurrent venous thromboembolism or know hereditary thrombophilia
Poorly compensated or uncontrolled cardiovascular disease

Show all 31Show fewer

Any major cardiovascular event within the last 12 months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, hospitalization due to unstable angina, transient ischemic attack, or stroke)
Any angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
New York Heart Association (NYHA) class III or IV congestive heart failure
Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mm Hg
Poorly controlled arrhythmia
Severe valvular disease
LDL cholesterol >160 mg/dl with known history of any major cardiovascular event, as defined above, within the last 12 months
Baseline EKG findings (e.g. left bundle branch block) or marked EKG abnormalities that would preclude serial screening for occult ischemic events
Current prostate, breast, or other organ cancer
History of prostate, breast, or other organ cancer, with the exceptions of completely resolved basal or squamous cell carcinoma for a duration of >24 months or completely resolved melanoma for a duration of >24 months
Serum prostate-specific antigen (PSA) >3.0 ng/ml
History of benign prostate enlargement (BPE) >40cc, evaluated via TRUS
Hematocrit >47%
Liver enzymes (AST / ALT) above normal upper limit
Creatinine >1.4 mg/dL
Serum calcium >10.5 mg/dL
Gynecomastia
Mental state that precludes understanding of the protocol
Diagnosed, but untreated moderate or severe sleep apnea
Spinal nutrition screening tool score >15
Severe claustrophobia that precludes MRI testing
Current anticoagulant therapy
Use of any of the following pharmacologic agents in the previous 3 months (testosterone, leuprolide, androgenic hormones, growth hormone, oral androgen precursors, 5-alpha reductase or aromatase inhibitors)
Use of anti-resorptive or bone anabolic drug therapy in the previous 6 months
Known allergy to sesame oil

Trial locations and contacts

2 sites in 1 country.

United States2 sites

North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI

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.

Read the detailed description

Men with spinal cord injury (SCI) experience a high prevalence of hypogonadism which influences the neural, muscular, skeletal, and body composition deficits that occur after injury. It remains unknown whether testosterone administration improves bone mineral density, muscle mass and muscle function, and body composition / metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. In addition, it is unknown whether testosterone or the 5-alpha reduced metabolite dihydrotestosterone (an endogenous metabolite of testosterone) mediate effects in these and other tissues.

For this study hypogonadal men with motor incomplete spinal cord injury who present with ambulatory dysfunction will be randomized to receive testosterone plus the 5-alpha reductase inhibitor finasteride or a placebo treatment for 12 months. Testosterone or placebo injection will be administered weekly; finasteride or placebo will be administered daily. Participants will be assessed at study entry and at 1-6 month intervals thereafter. Assessments will include measurements such as a dual energy x-ray absorptiometry (DEXA) scan, MRI scan, and muscle performance tests. Participants will also have several safety tests, including electrocardiogram (EKG) for cardiac electrophysiology, prostate digital rectal exam and prostate ultrasound sizing for prostate health, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate specific antigen (PSA), cholesterol, and other health markers.

Conditions: Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases
Being tested: Testosterone Enanthate, Finasteride, Placebo injection, Placebo pill
Keywords: Testosterone, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone, Androgens, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiologic Effects of Drugs, Pharmacologic Actions, Antineoplastic Agents, Hormonal, Antineoplastic Agents, Therapeutic Uses, Anabolic Agents, Testosterone Replacement Therapy, Dual Energy X ray Absorptiometry, Lean Tissue Mass, Body Composition, Lipid and Glucose profile, Muscle Strength
Medical subject headings: Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testosterone EnanthateDrug
Also called delatestryl
Subjects receive testosterone (125 mg/week) by intramuscular injection
FinasterideDrug
Also called proscar
Subjects receive finasteride (5 mg/day) orally
Placebo injectionDrug
Also called sesame oil
Subjects receive placebo (weekly) by intramuscular injection
Placebo pillDrug
Also called inactive substance
Subjects receive placebo pill (daily) orally

Study groups in NCT02248701
Study group	Role	What they receive
testosterone enanthate, finasteride	Experimental	Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day) Receives: Drug: Testosterone Enanthate; Drug: Finasteride
placebo treatment	Placebo comparator	Placebo via i.m. injection (once weekly) and placebo pill orally (daily) Receives: Drug: Placebo injection; Drug: Placebo pill

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Hip Bone Mineral Density
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Measured: Baseline, 6 months, 12 months
Percent Changes in Muscle Cross-Sectional Area
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Measured: Baseline, 6 months, 12 months
Percent Change in Total Body Fat
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Measured: Baseline, 6 months, 12 months
Absolute Change in Walking Speed
Absolute change in 10 m walking speed
Measured: Baseline, 6 months, 12 months

Secondary outcomes (2)

Percent Change in Neuromuscular Function
Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
Measured: Baseline, 6 months, 12 months
Percent Change in Visceral Fat
Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)
Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 201713 Aug 2021

First posted25 Sep 2014 (estimated)
Study start27 Apr 2017
Primary completion13 Aug 2021
Study completion13 Aug 2021

Why it stopped: Enrollment difficulties

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02248701
Sponsor's protocol ID: B1449-R
Other IDs: 1I01RX001449-01A1
Status last verified: Sep 2023
First submitted: 22 Sep 2014
Last updated: 29 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.

Publications

Otzel DM, Nichols L, Conover CF, Marangi SA, Kura JR, Iannaccone DK, Clark DJ, Gregory CM, Sonntag CF, Wokhlu A, Ghayee HK, McPhaul MJ, Levy CE, Plumlee CA, Sammel RB, White KT, Yarrow JF. Musculoskeletal and body composition response to high-dose testosterone with finasteride after chronic incomplete spinal cord injury-a randomized, double-blind, and placebo-controlled pilot study. Front Neurol. 2024 Dec 11;15:1479264. doi: 10.3389/fneur.2024.1479264. eCollection 2024.
PubMed 39722695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
ClinicalTrials.gov ID: NCT02248701
Acronym / sponsor ID: B1449-R
Conditions: Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases
Keywords: Testosterone, Testosterone enanthate, Testosterone undecanoate, Testosterone 17 beta-cypionate, Methyltestosterone, Androgens, Hormones, Hormone Substitutes, and Hormone Antagonists
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment difficulties
Enrolment: 33 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of Florida
Study start: 27 Apr 2017 (actual)
Primary completion: 13 Aug 2021 (actual)
Study completion: 13 Aug 2021 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 29 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
testosterone enanthate, finasteride	Experimental	Drug: Testosterone Enanthate, Drug: FinasterideTestosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
placebo treatment	Placebo comparator	Drug: Placebo injection, Drug: Placebo pillPlacebo via i.m. injection (once weekly) and placebo pill orally (daily)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male > 18 years of age
Traumatic, vascular, or orthopedic spinal cord injury between C2-L3 >12 months prior to enrollment
Motor incomplete spinal cord (AIS C/D)
Ambulatory dysfunction
Medically stable condition that is asymptomatic for bladder infection, decubiti, cardiopulmonary disease, or other significant medical conditions

Key exclusion criteria (31 listed)

Currently participating in another research protocol that may influence study outcomes
Life expectancy <1 year
History of or current congenital spinal cord injury or other degenerative spinal disorder
Diagnosis of multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment/injury
History of venous thromboembolism within the last 6 months, specifically deep venous thromboembolism and pulmonary embolism, history of recurrent venous thromboembolism or know hereditary thrombophilia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testosterone EnanthateAlso: delatestrylSubjects receive testosterone (125 mg/week) by intramuscular injection	Drug	testosterone enanthate, finasteride
FinasterideAlso: proscarSubjects receive finasteride (5 mg/day) orally	Drug	testosterone enanthate, finasteride
Placebo injectionAlso: sesame oilSubjects receive placebo (weekly) by intramuscular injection	Drug	placebo treatment
Placebo pillAlso: inactive substanceSubjects receive placebo pill (daily) orally	Drug	placebo treatment

Primary outcome

Percent Change in Hip Bone Mineral Density
Time frame: 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)
Percent Changes in Muscle Cross-Sectional Area
Time frame: Baseline, 6 months, 12 months
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Percent Change in Total Body Fat
Time frame: Baseline, 6 months, 12 months
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Absolute Change in Walking Speed
Time frame: Baseline, 6 months, 12 months
Absolute change in 10 m walking speed

2 secondary outcomes

Percent Change in Neuromuscular Function
Time frame: Baseline, 6 months, 12 months
Percent Change in Visceral Fat
Time frame: Baseline, 6 months, 12 months

Results and safety

Results posted to the registry on 29 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone Enanthate, Finasteride	7	3
Placebo Treatment	5	3

Primary outcome: Percent Change in Hip Bone Mineral Density

Time frame: Baseline, 6 months, 12 months. Mean (Standard Deviation). Unit: percent change

Measure	Testosterone Enanthate, Finasteride n = 5	Placebo Treatment n = 5
Change at 6 months	1.7 (4.7)	-0.5 (2.4)
Change at 12 months	1.2 (7.3)	1.1 (4.9)

Population analysed: 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.

Primary outcome: Percent Changes in Muscle Cross-Sectional Area

Time frame: Baseline, 6 months, 12 months. Mean (Standard Deviation). Unit: percent change

Measure	Testosterone Enanthate, Finasteride n = 5	Placebo Treatment n = 4
6 months	7.9 (4.4)	-0.9 (4.1)
12 months	11.4 (6.0)	-1.9 (4.3)

Population analysed: 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.

Primary outcome: Percent Change in Total Body Fat

Time frame: Baseline, 6 months, 12 months. Mean (Standard Deviation). Unit: percent change

Measure	Testosterone Enanthate, Finasteride n = 4	Placebo Treatment n = 5
6 months	-6.8 (5.0)	-4.7 (10.6)
12 months	-8.7 (8.4)	-1.9 (9.1)

Population analysed: 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.

Primary outcome: Absolute Change in Walking Speed

Time frame: Baseline, 6 months, 12 months. Mean (Standard Deviation). Unit: meters/second (m/s) change

Measure	Testosterone Enanthate, Finasteride n = 5	Placebo Treatment n = 5
6 months	0 (0.17)	0.05 (0.14)
12 months	0.10 (0.12)	0.01 (0.15)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone Enanthate, Finasteride	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7
Placebo Treatment	0 of 5 (0%)	5 of 5 (100%)	0 of 5

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39722695Otzel DM, Nichols L, Conover CF, Marangi SA, Kura JR, Iannaccone DK, Clark DJ, Gregory CM, Sonntag CF, Wokhlu A, Ghayee HK, McPhaul MJ, Levy CE, Plumlee CA, Sammel RB, White KT, Yarrow JF. Musculoskeletal and body composition response to high-dose testosterone with finasteride after chronic incomplete spinal cord injury-a randomized, double-blind, and placebo-controlled pilot study. Front Neurol. 2024 Dec 11;15:1479264. doi: 10.3389/fneur.2024.1479264. eCollection 2024.
Individual participant dataSharing planned: Yes. Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joshua F Yarrow, PhD MS BS principal investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Dana M Otzel, PhD principal investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone Enanthate and Finasteride in people with Spinal Cord Injury and Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Hip Bone Mineral Density (time frame: Baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02248701, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.