Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Background: Menā„65 years often produce lower levels of testosterone, meaning there is less
testosterone circulating to the tissues of the body. This is associated with negative effects
on muscle strength, bone density, sexual function, mood, and the ability to think to the best
of one's ability. Testosterone replacement therapy often involves injections, patches, or
gels that help to raise circulating testosterone levels, but these therapies often have side
effects because they lead to imbalance of other hormones. Researchers have been studying the
effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously
increasing testosterone levels, as a treatment for the negative effects of decreased
circulating testosterone levels that occur naturally with aging. Objectives: To evaluate
whether anastrozole is as effective as testosterone gel in improving bone and muscle
strength, hormone levels, and brain function in men over 65 years of age. Eligibility:
Healthy men at least 65 years of age who have low levels of testosterone. Design: The study
involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,
6 months, and 12 months. All participants will receive calcium and vitamin D supplements to
take daily, and will be randomized to one of three groups:Testosterone gel and placebo
tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have
the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to
evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle
strength, bone density, and balance evaluation; imaging studies; cognitive testing; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine
tests; growth hormone, muscle strength, bone density, and balance evaluation; and
questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
months: Blood and urine tests; muscle strength, bone density, and balance evaluation;
cognitive testing; and questionnaires on quality of life, sexual function, depression, and
urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,
bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires
on quality of life, sexual function, depression, and urinary symptoms.