One of three doses of testosterone gel were given
to 93 hypogonadal men, average age 52 years.
Patients were started on 5 g/day and 10 g/day,
with some subjects later adjusted to 7.5 g/day in
order to achieve testosterone levels in the normal
range. There were no control subjects. Before
treatment, the men had serum total testosterone
levels below 10 nmol/L and free testosterone
levels of less than 0.2 nmol/L.
Andropause - Male
Menopause
Testosterone replacement options:
Guidelines Take New Look at Management of
Hypogonadism in Men
By
eInternal Medicine News: Michele G.
Sullivan
Feb
16, 2003, 11:39am
Updated
guidelines on diagnosis and treatment of
hypogonadism in men reflect advances in treatment
and more robust data about the short-term benefits
of testosterone replacement therapy.
The
guidelines, issued by the American Association of
Clinical Endocrinologists (AACE), also urge
additional research into the long-term use of the
therapy and its possible effects on the risks of
cancer and cardiovascular disease.
“Concern
about long-term safety and efficacy remains an
issue,” said Dr. Steven M. Petak, chair of the
guidelines revision committee.
“Perhaps
these new guidelines will stimulate some
additional research into these issues,” said Dr.
Petak, an endocrinologist at the Texas Institute
for Reproductive Medicine and Endocrinology,
Houston.
The
National Institute on Aging has begun work on a 1-
year study to evaluate the feasibility of
conducting clinical trials of testosterone
replacement therapy in older men. A task force
will report on the known benefits and risks of the
therapy, its potential public health impact, and
the ethical issues involved in conducting such a
clinical trial. The report is expected by
November, said Dr. Stanley Slater, deputy director
of the institute's geriatrics and clinical
gerontology program.
The new
AACE guidelines include a detailed discussion of
clinical and laboratory findings, plus a diagnosis
and treatment algorithm based on testicular size,
hormone levels, and semen analysis. The revision
is the first since the guidelines were initially
issued in 1996.
It's
important to focus attention on the recognition
and treatment of the disorder because many men are
reluctant to discuss the symptoms of hypogonadism
with their physicians. Symptoms usually include
decreased libido, impotence, decreased muscle
mass, fatigue, and decreased bone
density.
“Many men
don't seek out medical attention for health
problems in the early stage,” Dr. Petak said. “And
they don't feel comfortable talking about the
major symptom, loss of libido.”
Even if
patients do mention decreased sexual urge,
physicians might be more likely to prescribe
Viagra than to perform a full evaluation. “Lots of
physicians don't delve into the matter too deeply,
either for lack of time or because of the level of
discomfort,” he said. A thorough evaluation is
important because hypogonadism may arise from
problems with the testes, pituitary, or
hypothalamus, or by a genetic disorder.
The AACE
guidelines are aimed at three target
populations:
Men with
primary testicular failure who require hormone
replacement.
Men with
gonadotropin deficiency or dysfunction who may
have received testosterone replacement therapy or
treatment for infertility.
Aging men
whose could benefit from testosterone
therapy.
Diagnostic criteria are based on
physical assessment, hormone levels, dynamic
testing (GnRH and clomiphene stimulation tests),
and semen analysis. Additional diagnostic studies
include bone densitometry, pituitary imaging,
genetic studies, testicular biopsy, and scrotal
exploration.
No studies have clearly
indicated that a particular testosterone level is
associated with pituitary tumors. But a total
testosterone level of less than 150 ng/dL should
trigger a pituitary imaging study, even in the
absence of other symptoms, the guidelines
state.
The treatment goal is the same
in each target population—to restore sexual
function (including fertility, if desired and
possible), libido, behavior, and physical well-
being. In addition to decreased sex drive and
sexual activity, men with low testosterone levels
may exhibit anger, depression, fatigue, and
confusion, as well as physical effects such as
decreased muscle mass and bone density and
associated osteoporosis.
Based on the results of recent
studies, the new guidelines state that
testosterone replacement often alleviates
associated psychological conditions, increases
virilization, and optimizes bone density. Recent
studies also indicate that the therapy may
normalize growth hormone levels in elderly men.
Therapy also may decrease cardiac mortality in
this population, but the guidelines make no
specific recommendations in this area because the
link between cardiovascular disease and low
testosterone is not fully understood.
The AACE
guidelines evaluate testosterone replacement
methods (injection, patch, gel, and oral agents)
and stress that patients on testosterone
replacement need to be carefully monitored for
possible adverse effects. Careful monitoring of
prostate-specific antigen is particularly
important, and men with known prostate cancer
should never use testosterone replacement
therapy.
The full
guidelines are available online at
www.aace.com/clin/guidelines.
United Medical Network - Testosterone May Boost
Endurance In Heart Failure
Andropause - Male
Menopause
Testosterone May Boost Endurance
In Heart Failure
By eInternal Medicine News: by
Timothy F. Kirn
Dec 22, 2002,
8:55pm
Testosterone therapy was
associated with a 95-meter improvement on the
shuttle walk test in a double-blind study of 20
heart failure patients, Dr. T. Hugh Jones said at
the annual meeting of the Endocrinology
Society.
The patients, men with ejection
fractions of around 35%, increased their distance
walked during the test from an average 280 m to an
average 375 m—an increase of 34%—after 12 weeks of
testosterone therapy. In contrast, patients who
received placebo increased their distance by an
average of 2%. Testosterone was given as 100-mg
injections delivered once every 2 weeks in the
trial.
A larger, confirmatory trial is
underway, Dr. Jones of the academic unit of
endocrinology at the University of Sheffield
(England) said in a press conference.
Low testosterone levels may
contribute to exercise intolerance and general
fatigue in men with heart failure. Testosterone
can promote vasodilatation and may have some
beneficial anti-inflammatory properties.
There was no evidence that
testosterone increased skeletal muscle strength or
bulk, or that it changed plasma levels of
proinflammatory cytokines, Dr. Jones
said.
By THE NEW
YORKER : JEROME GROOPMAN
Nov
30, 2002, 11:32am
It goes by
many names. "Male menopause" is perhaps the most
popular, but "andropause" is the term that many
doctors favor, and PADAM ("partial androgen
deficiency in aging men") has its partisans, too.
The condition may afflict millions of Americans,
and, if they do not yet recognize the symptoms, a
public-awareness campaign has been launched to
help them. A two-page ad that ran in Time not long
ago showed a car's gas gauge pointing to Empty and
beside it the words "Fatigued? Depressed mood? Low
sex drive? Could be your testosterone is running
on empty." The ad explains that "as some men grow
older, their testosterone levels decline," and
that such men should consult their doctors about
testosterone therapy. At the bottom of the page,
the gas gauge points to Full.
Physicians
have been targeted with similar ads. One that
appeared in a recent issue of a primary-care
journal calls on them to "identify the men in your
practice with low testosterone who may benefit
from clinical performance in a packet." The
photographs are eye-catching: there's a well-built
fellow in his middle years beside the
words "improved sexual function"; a smiling man in
shorts and a T-shirt who is standing next to a
mountain bike ("improved mood"); a policeman
directing traffic ("increased bone mineral
density"). Doctors are told to "screen for
symptoms of low testosterone" and "restore normal
testosterone levels."
These ads
were paid for by Unimed, a division of the Belgian
conglomerate Solvay. Unimed makes AndroGel, a drug
that was approved by the F.D.A. two years ago, and
is the fastest-growing form of testosterone-
replacement therapy for men. Pills, introduced in
the sixties, often caused liver damage.
Intramuscular injections, particularly favored by
bodybuilders and competitive athletes, produce a
sharp spike of the hormone, and then a fall, and
these fluctuations are often accompanied by swings
in mood, libido, and energy. In the late eighties,
a transdermal patch was developed, and its use is
still widespread. The patch provides safer and
steadier dosing, but often causes skin irritation,
and sometimes falls off during exercise. AndroGel,
by contrast, delivers testosterone in a colorless,
drying gel that is simply rubbed on an area of the
body—usually the shoulders—once a day. It has thus
made testosterone available in a form that almost
any man can use conveniently.
If hormone-replacement therapy
for andropause becomes as common as such therapies
have been for menopause—and this seems to be the
ambition of some drug companies—the consequences,
both medical and financial, could be dramatic.
Given the popular desire to reverse human aging
with a simple nostrum and the growing intimacy
between commercial and clinical concerns, the
trend may prove to be irresistible. The
pharmaceutical industry is, of course, in the
business of inventing treatments. Some people
wonder whether it may help invent diseases,
too.
To be
treated for andropause, you first need physicians
who can confidently make the diagnosis. One of
them is Dr. Abraham Morgentaler, the director of
Men's Health Boston. He is forty-six years old,
with thick black hair and deep-set eyes. Trained
as a urologist, he specializes in male sexual
dysfunction and infertility. He views testosterone
deficiency in older men as a silent epidemic, and
worries that, of the perhaps five million American
men who suffer from it, ninety-five per cent go
undiagnosed. Replacing missing testosterone, he
believes, will help restore youthful muscle tone,
bone strength, potency, and general vigor. He
recently put an ad in the Boston Globe urging men
who were experiencing "low sex drive" or "low
energy" to have their testosterone level tested at
his clinic. The costs of both the ad and the tests
were underwritten by a Unimed educational
grant.
Men's
Health Boston is in a modern brick-and-glass
office building at a busy intersection in
Brookline. It has a well-appointed waiting room
with soft lighting and upholstered chairs;
photographs of famous local athletes adorn the
walls. The men who came to see Morgentaler on a
recent afternoon had all been given a
questionnaire provided by Unimed:
1. Do you
have a decrease in libido (sex drive)?
2. Do you
have a lack of energy?
3. Do you
have a decrease in strength and/or endurance?
4. Have you
lost height?
5. Have you
noticed a decreased "enjoyment of life"?
6. Are you
sad and/or grumpy?
7. Are your
erections less strong?
8. Have you
noticed a recent deterioration in your ability to
play sports?
9. Are you
falling asleep after dinner?
10. Has
there been a recent deterioration in your work
performance?
Among the
patients was a real-estate broker in his late
fifties. He had answered "Yes" to questions 1, 2,
3, 5, 7, and 10. "I'm just exhausted by the end of
the afternoon," he said, after Morgentaler gave
him a physical. "And my brain often feels foggy."
He likes to shoot pool, and he remarked that his
game wasn't what it used to be.
"Have you
noticed any change in sexual performance?" Dr.
Morgentaler asked.
"Well, I'm
not a kid anymore," the patient said, but he had
no real complaints.
Morgentaler
then showed the man the results from his blood
assay. His testosterone levels were "somewhat
low," Morgentaler said. "Now, if I had a magic
wand and I could do anything for you, what would
it be?"
"Fix the
energy thing."
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