5-Alpha Reductase and Anabolic Effects of Testosterone
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Male Hypogonadism; Muscle Atrophy; Sarcopenia; Benign Prostate Hypertrophy
Intervention: Testosterone Enanthate (Drug); Finasteride (Drug); Testosterone Enanthate (Drug); Finasteride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Stephen Borst, PhD, Principal Investigator, Affiliation: North Florida/South Georgia Veterans Health System
Summary
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.
Clinical Details
Official title: 5-Alpha Reductase and Anabolic Effects of Testosterone
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 1 Repetition Maximum (1-RM) Strength Testing
Secondary outcome: Grip Strength kgLumbar Spine L2-L4 Bone Mineral Density Geriatric Depression Scale 30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test Trail-Making Test, Part A Benton Judgment of Line Orientation Test Hematocrit Dietary Protein Intake Transrectal Ultrasound Sizing of Prostate Life Satisfaction
Detailed description:
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- repetition maximum (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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age > 60 years males
- Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida.
- 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 as assessed by elevated American Urologic
Association Symptom Index (AUASI) score > 25), congestive heart failure (Class 3 or
4), sleep apnea syndrome, polycythemia (Hct > 55%), or prostate specific antigen
(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.
Locations and Contacts
North Florida/South Georgia Veterans Health System, Gainesville, Florida 32608, United States
Additional Information
Starting date: January 2007
Last updated: December 4, 2014
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