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Are you a
man over 65 with low testosterone?
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This study is currently recruiting
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Sponsored by:
National Institute
on Aging |
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Enrollment Start
Date: August 2004 |
End date:
Until requirements are met
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| Title: |
The Effects of Aromatase Inhibition on
Sex Steroids, Pituitary Hormones, Markers of Bone
Turnover, Muscle Strength and Cognition on Older
Men |
| Summary: |
We are looking for men over 65 with low
testosterone to participate
in a
research study which is trying to improve upon men's health.
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| Purpose: |
The purpose of this study is to determine if an aromatase inhibitor (a drug
that inhibits the conversion of testosterone to estrogen)
is as effective as testosterone replacement in improving muscle mass, muscle
strength, sexual function, memory, and bone health. |
| Description: |
Approximately 20% of men over the age of 70 have
low testosterone levels. In some studies, testosterone replacement
has resulted in improvement in bone mass, muscle strength, quality
of life and memory function. In the body, testosterone is converted
into estrogen. Hence, it is unclear whether these beneficial effects
are due to testosterone or estrogen. Research has shown that
inhibition of estrogen production in men results in an increase in
testosterone levels.
In this study, patients will be assigned to
one of three groups: one group will receive testosterone gel and a
placebo tablet, one group will receive a 1mg Anastrozole tablet and
a placebo gel, and one group will receive a placebo tablet and
placebo gel. Each group will receive a daily dose of calcium with
vitamin D. The study requires 6 visits over a 12-month period for
testing and evaluation. Two of the 6 visits will require an
overnight stay in the hospital so that an intravenous (IV) line can
be placed in the arm to allow samples to be drawn throughout the
night. Testing will include a cardiac stress test, a glucose
tolerance test, bone and muscle tests, evaluation of memory
function, etc. For the safety of the prostate, we will perform a
prostate ultrasound at the start and end of the study and we will
monitor urinary symptoms, prostate specific antigen (PSA) levels and
the prostate exam throughout the study.
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| Eligibility |
Inclusion
Criteria:
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Male
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65 years
of age or older
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Testosterone level less than 350 ng/dl (we will check this level
at the screening visit)
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Able to
complete an informed consent
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Exclusion
Criteria:
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History of Stroke
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History of Dementia
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History of Diabetes
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Blood Pressure at rest
of > 155/90 mm Hg
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Chronic medical condition
(i.e. heart failure, rheumatoid arthritis)
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On osteoporosis medications
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On steroids (prednisone, cortisone)
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History of gastric surgery
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History of any
Cancer (except non-melanoma skin cancers)
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Drink more than 2 beers OR 1 glass
of wine or cocktail daily
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Smoke any tobacco product
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History of joint replacement
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| Principal
Investigator: |
Josephine M.
Egan, MD |
| Location: |
National Institute on Aging, National Institutes
of Health
at Harbor Hospital, 5th Floor
3001 South Hanover
Street
Baltimore, MD 21225
410-350-3941
or 1-800-225-2572 ext 3941
Conveniently located just
minutes from I-95, I-895, and Ritchie Highway
(Route 2) in South Baltimore. |
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Contact
Information: |
NIA Recruitment 410-350-3941 or email us
Reference Number:IRB
2003-307 |
MedStar Research Institute is the research center
for MedStar Health, the Baltimore/Washington area's largest healthcare
delivery system. The purpose of the Institute is to conduct and
support medical research that results in better treatments and prevention
strategies for the major diseases affecting the communities we
serve. The Institute's areas of research strength include
cardiovascular disease, oncology, diabetes, obesity, neuroscience,
maternal and child health, orthopedics/sports medicine, critical care,
bioterrorism, hematology and
epidemiology.
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