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Spinal Cord InjuryPhase 2/3NCT00266864

Testosterone Replacement Therapy in Chronic Spinal Cord Injury

A Phase 2/3 study testing Testosterone Transdermal System (Androderm 5 mg patch) in people with Spinal Cord Injury and Hypogonadism, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. Read more about this study

Who is it for?
Ages 18 to 49 years, men only
Conditions the study is for
Spinal Cord Injury, Hypogonadism
What is being tested?
Testosterone Transdermal System (Androderm 5 mg patch)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
Aug 2003to Dec 2012
Phase
Phase 2/3
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 to 49 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males 18-49 years of age
  • Chronic spinal cord injury
  • Normal prostate specific antigen levels and digital rectal exam
  • No known cardiovascular disease
  • Subjects with total testosterone > 4 ng/ml
  • Subjects with total testosterone > 4 ng/ml

Who cannot join

  • Females
  • Known coronary heart and/or artery disease, diabetes mellitus
  • Previous or current cancer
  • Current or previous anabolic steroid use
  • Acute inter-current illness
  • Abnormal liver function test (>1.5 times normal values) at baseline
Show all 10Show fewer
  • Prostate specific antigen above normal
  • Abnormal digital rectal exam at baseline suggestive of malignancy
  • Current alcohol or drug abuse
  • Significant psychological disorders

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:

body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment

Read the detailed description

This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.

Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.

Being tested
Testosterone Transdermal System (Androderm 5 mg patch)
Keywords
Spinal Cord Injury, Testosterone Replacement Therapy, Dual Energy X ray Absorptiometry, Lean Tissue Mass
Medical subject headings
Spinal Cord Injuries, Hypogonadism

What participants receive

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

  • Testosterone Transdermal System (Androderm 5 mg patch)Drug

    Also called Androgel (Testim) and Underarm Testosterone (Axiron)

    Testosterone Transdermal System (Androderm 5 mg patch)

Study groups in NCT00266864
Study groupRoleWhat they receive
Testosterone Replacement TherapyExperimentalSubjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
Receives: Drug: Testosterone Transdermal System (Androderm 5 mg patch)
No InterventionNo interventionSubjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.

What is being measured

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

  1. Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)

    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.

    Measured: 12 months

Secondary outcomes (1)

  1. Resting Energy Expenditure

    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.

    Measured: 12 months

Timeline

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

  1. First posted19 Dec 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionAug 2012
  4. Study completionDec 2012

Resources

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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00266864
Sponsor's protocol ID
B2648-C
Status last verified
Sep 2017
First submitted
15 Dec 2005
Last updated
1 Nov 2017
Data monitoring committee
No

Publications

  • Bauman WA, Cirnigliaro CM, La Fountaine MF, Jensen AM, Wecht JM, Kirshblum SC, Spungen AM. A small-scale clinical trial to determine the safety and efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury. Horm Metab Res. 2011 Jul;43(8):574-9. doi: 10.1055/s-0031-1280797. Epub 2011 Jun 29.

    PubMed 21717386

  • La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. QT/RR coherence is associated with testosterone levels in men with chronic spinal cord injury. Neuroendocrinology. 2011;93(3):174-80. doi: 10.1159/000323773. Epub 2011 Jan 21.

    PubMed 21252493

  • La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. Testosterone replacement therapy improves QTaVI in hypogonadal men with spinal cord injury. Neuroendocrinology. 2013;97(4):341-6. doi: 10.1159/000347070. Epub 2013 May 9.

    PubMed 23343764

  • Bauman WA, La Fountaine MF, Cirnigliaro CM, Kirshblum SC, Spungen AM. Lean tissue mass and energy expenditure are retained in hypogonadal men with spinal cord injury after discontinuation of testosterone replacement therapy. J Spinal Cord Med. 2015 Jan;38(1):38-47. doi: 10.1179/2045772314Y.0000000206. Epub 2014 Jun 26.

    PubMed 24968251

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Testosterone Transdermal System (Androderm 5 mg patch) in people with Spinal Cord Injury and Hypogonadism, 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 10 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: finished, as of the sponsor's last update on 1 Nov 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Apr 2014). 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?

Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) (time frame: 12 months). 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 NCT00266864, which also lists 4 linked publications.

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 1 Nov 2017.

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