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Testosterone Replacement Therapy in Chronic Spinal Cord Injury

NCT ID: NCT00266864

Last Updated: 2017-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Spinal Cord Injury Hypogonadism

Keywords

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Spinal Cord Injury Testosterone Replacement Therapy Dual Energy X ray Absorptiometry Lean Tissue Mass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testosterone Replacement Therapy

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

Group Type EXPERIMENTAL

Testosterone Transdermal System (Androderm 5 mg patch)

Intervention Type DRUG

Testosterone Transdermal System (Androderm 5 mg patch)

No Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Testosterone Transdermal System (Androderm 5 mg patch)

Testosterone Transdermal System (Androderm 5 mg patch)

Intervention Type DRUG

Other Intervention Names

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Androgel (Testim) and Underarm Testosterone (Axiron)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kessler Institute for Rehabilitation

INDUSTRY

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Bronx

Locations

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Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Site Status

James J. Peters VA Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21717386 (View on PubMed)

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.

Reference Type RESULT
PMID: 21252493 (View on PubMed)

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.

Reference Type RESULT
PMID: 23343764 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24968251 (View on PubMed)

Related Links

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http://www.unitedspinal.org

Click here for more information about this study: Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Other Identifiers

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B2648-C

Identifier Type: -

Identifier Source: org_study_id