NCT00266864

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

9 years

First QC Date

December 15, 2005

Results QC Date

December 19, 2013

Last Update Submit

September 29, 2017

Conditions

Spinal Cord InjuryHypogonadism

Keywords

Spinal Cord InjuryTestosterone Replacement TherapyDual Energy X ray AbsorptiometryLean Tissue Mass

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (1)

  • Resting Energy Expenditure

    12 months

Study Arms (2)

Testosterone Replacement Therapy

EXPERIMENTAL

Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)

Drug: Testosterone Transdermal System (Androderm 5 mg patch)

No Intervention

NO INTERVENTION

Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.

Interventions

Testosterone Transdermal System (Androderm 5 mg patch)DRUG

Testosterone Transdermal System (Androderm 5 mg patch)

Also known as: Androgel (Testim) and Underarm Testosterone (Axiron)
Testosterone Replacement Therapy

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Prostate specific antigen above normal
  • Abnormal digital rectal exam at baseline suggestive of malignancy
  • Current alcohol or drug abuse
  • Significant psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (4)

  • 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.

    PMID: 21717386RESULT

  • 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.

    PMID: 21252493RESULT

  • 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.

    PMID: 23343764RESULT

  • 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.

    PMID: 24968251DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesHypogonadism

Interventions

TestosteroneTransdermal PatchTestosterone Propionate

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEquipment and Supplies

Limitations and Caveats

Compared to similar trials our trial was relatively small. Although there was statistical and clinical changes associated with testosterone replacement therapy, the translation of these findings with regard to functional gain was not addressed.

Results Point of Contact

Title
William A. Bauman, M.D.
Organization
James J. Peters VA Medical Center
william.bauman@va.gov
718-584-9000

Study Officials

  • William Bauman, MD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 19, 2005

Study Start

August 1, 2003

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

November 1, 2017

Results First Posted

April 7, 2014

Record last verified: 2017-09

Locations

US(2)