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Anabolic Therapies: New Hope for Treating Secondary Disabilities of SCI
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, December 2009
First Received: December 15, 2005   Last Updated: December 29, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Collaborator: Kessler Institute for Rehabilitation
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00266864
  Purpose

It has long been recognized that co-morbidities associated with the multiple metabolic syndrome (MMS), 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-morbidities 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


Condition Intervention Phase
Hypogonadism
Spinal Cord Injury
Drug: Testosterone Replacement Therapy Patch 5mg daily
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Changes to body composition, metabolism, strength and cardiovascular autonomic control [ Time Frame: 12/31/2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2003
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Testosterone Replacement Therapy Patch 5mg daily
Testosterone Replacement Therapy Patch 5mg daily

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 4 ng/ml will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5mg/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 (> 4ng/ml) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males 18-60 years of age
  • Chronic SCI
  • Normal PSA levels and rectal exam
  • No known cardiovascular disease
  • 40 subjects with hypogonadism [low serum total testosterone (Total > 4 ng/ml)]
  • 10 subjects with eugonadism (Total > 4ng/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
  • PSA above normal
  • Abnormal DRE at baseline suggestive of malignancy
  • Current alcohol or drug abuse
  • Significant psychological disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266864

Contacts
Contact: Shevana Swaby, BS (718) 584-9000 ext 3123 shevana.swaby@va.gov
Contact: Chris Cirnigliaro, MS (973) 731-3900 ext 2755 ccirnig@yahoo.com

Locations
United States, New Jersey
Kessler Instsitute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Chris Cirnigliaro, MS     973-731-3600 ext 2755     christopher.cirnigliaro@va.gov    
United States, New York
VA Medical Center, Bronx Active, not recruiting
Bronx, New York, United States, 10468
Sponsors and Collaborators
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: William Bauman, MD VA Medical Center, Bronx
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs ( Bauman, William - Principal Investigator )
Study ID Numbers: B2648C
Study First Received: December 15, 2005
Last Updated: December 29, 2009
ClinicalTrials.gov Identifier: NCT00266864     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Eugonadism
Hypogonadism
Spinal Cord Injury
Testes
Testosterone

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Spinal Cord Diseases
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Wounds and Injuries
Endocrine System Diseases
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Spinal Cord Injuries
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010