Testosterone Replacement Therapy in Chronic Spinal Cord Injury
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00266864 |
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Recruitment Status :
Completed
First Posted : December 19, 2005
Results First Posted : April 7, 2014
Last Update Posted : November 1, 2017
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injury Hypogonadism | Drug: Testosterone Transdermal System (Androderm 5 mg patch) | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 31 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Testosterone Replacement Therapy in Chronic Spinal Cord Injury |
| Study Start Date : | August 2003 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Testosterone Replacement Therapy
Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
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Drug: Testosterone Transdermal System (Androderm 5 mg patch)
Testosterone Transdermal System (Androderm 5 mg patch)
Other Name: Androgel (Testim) and Underarm Testosterone (Axiron) |
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No Intervention: No Intervention
Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
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- Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) [ Time Frame: 12 months ]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.
- Resting Energy Expenditure [ Time Frame: 12 months ]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.
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266864
| United States, New Jersey | |
| Kessler Institute for Rehabilitation | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| James J. Peters VA Medical Center | |
| The Bronx, New York, United States, 10468 | |
| Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00266864 |
| Other Study ID Numbers: |
B2648-C |
| First Posted: | December 19, 2005 Key Record Dates |
| Results First Posted: | April 7, 2014 |
| Last Update Posted: | November 1, 2017 |
| Last Verified: | September 2017 |
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Spinal Cord Injury Testosterone Replacement Therapy Dual Energy X ray Absorptiometry Lean Tissue Mass |
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Spinal Cord Injuries Hypogonadism Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone |
Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |