| City: |
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Gainesville |
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State:
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FL |
| Zip Code: |
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32608 |
| Conditions: |
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Male Hypogonadism - Muscle Atrophy - Prostate Enlargement - Sarcopenia |
| Purpose: |
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The purpose of this study is to determine whether a higher-than-replacement dose of
testosterone and finasteride can be combined to safely increase muscle strength in older men
who have a low blood concentration of testosterone.
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| Study summary: |
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Approximately 40% of older male veterans have a low serum testosterone concentration. The
latter is associated with diminished muscle strength and bone mineral density, depressed
mood, low pain tolerance, frailty, and increased mortality. Replacement doses of
testosterone have been administered to hypogonadal men for the purpose of reversing deficits
in muscle and bone. Although testosterone is clearly important for maintaining muscle and
bone in men, there are problems associated with T replacement. First, testosterone causes a
number of undesired effects, including fluid retention, gynecomastia, worsening of sleep
apnea, polycythemia, prostate enlargement and acceleration of early-stage prostate cancer .
The anabolic effects obtained to date from testosterone replacement have been relatively
modest, especially in older men . Our hypothesis is that combined treatment with a
higher-than-replacement dose of testosterone and a 5- reductase inhibitor will produce
substantial anabolic effects, while preventing testosterone-induced prostate enlargement and
possibly other adverse effects.
We plan to investigate the efficacy and safety of combined treatment with testosterone and
finasteride in older hypogonadal male veterans by conducting a 12-month randomized,
placebo-controlled trial. We will administer a higher-than-replacement dose of testosterone
plus the 5- reductase inhibitor finasteride to a group of hypogonadal, but otherwise
healthy older men. We will determine whether this treatment is a safe and effective means
to increase muscle mass and strength. Men aged 60 to 80, with circulating total
testosterone 300 ng/dL or bioavailable testosterone 70 ng/dL, will be treated with 125
mg testosterone enanthate/week 5 mg finasteride/day for 1 year. We will assess the
effects on body composition, 1-RM strength, grip strength, functional reach, bone mineral
density, mood, cognition, hematopoiesis and prostate volume. We have chosen a moderately
high dose of testosterone that may cause some adverse effects. We predict that finasteride
will not block the anabolic effects of testosterone, but will block any prostate enlargement
or symptoms and possibly other adverse effects as well. |
| Criteria: |
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Inclusion Criteria:
- Age > 60 years males
- Primary care at the Malcolm Randall VA Medical Center in Gainesville, FL.
- Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total
testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no
exclusion criteria will be randomized to receive either testosterone or placebo.
Exclusion Criteria:
- Subjects with cognitive impairment will be identified by the Mini-Cog test and
excluded. The Mini-Cog has high sensitivity and specificity for cognitive impairment,
and is not affected by level of education.
- We will also exclude subjects with receptive aphasia, or a contraindication to
testosterone replacement (i.e., history of or active prostate or breast cancer,
severe benign prostatic hyperplasia (AUA SI > 25), congestive heart failure (Class 3
or 4), sleep apnea syndrome, polycythemia (Hct > 55%), or PSA > 2.6 ng/mL) will be
excluded.
- Obese subjects (BMI > 35) will also be excluded.
- Subjects currently receiving testosterone supplementation or subjects who have an
allergy to testosterone will also be excluded.
- Subjects previously receiving testosterone replacement therapy must be off such
medication for at least four weeks. |
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| Study is available at: |
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North Florida/South Georgia Veterans Health System
Gainesville, FL 32608
United States
Primary Contact:
Stephen Borst, PhD
Email: stephen.borst@va.gov
Secondary Contact:
Stephen Borst, PhD
Email: stephen.borst@va.gov |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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