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View Full Version : Testoderm® TTS ( TESTOSTERONE - TRANSDERMAL - SYSTEM ) PROFILE



akn
06-15-2014, 06:47 AM
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Description:
Testoderm® and Testoderm® TTS are testosterone delivery
systems that utilize a “patch” to deliver the hormone
transdermally. Both products were designed to deliver an
approximate 5 mg dose of testosterone to the body over a 24-
hour period, after which point the patch is replaced with a
fresh one. Testoderm is an older matrix-type skin patch,
which uses no penetration enhancers, so it must be applied
on the scrotum, where the skin is much more permeable to
testosterone. Testoderm TTS is a newer reservoir-type skin
patch containing an alcoholic gel of testosterone, which can
be placed on the arm, back, or upper buttocks. Testoderm
and Testoderm TTS are designed to mimic the natural
circadian rhythm of testosterone release in healthy young
men, higher during the first 12 hours and lower during the
next 12 hours of each day. The clinical significance of this, if
any, is not known.
Testoderm® was developed in the United States by Alza
Corporation, and introduced for sale in 1998. The drug is
FDA-approved for testosterone replacement therapy in men
with a deficiency or absence of endogenous testosterone. The
Testoderm system itself did not make use of any penetration
enhancers, and consequently is applied to an area of shaved
scrotal skin, which is about 5 times more permeable to
testosterone than normal body skin. Lacking an integrated
adhesive, Alza soon released an updated version of
Testoderm called simply Testoderm With Adhesive.
Testoderm was an effective androgen replacement product,
but did have the slight disadvantage of elevating DHT levels
in many patients due to the prominence of 5-alpha reductase
in the scrotum.592
Testoderm was ultimately the first testosterone patch to be
developed for commercial sale. While it was deemed a
success initially, it was soon obsolete next to the newer and
less intrusive Androderm patch (FDA approved in 1995).
Alza released Testoderm TTS in 1998, in an effort to retain
its share of the male androgen replacement market. The new
updated patch can be placed on three types of skin (back,
arms,and upper buttocks), and has the advantage of causing
less skin irritation next to Androderm. It also does not
require that the patient rotate application sites each day.
Since its approval in the U.S., Testoderm TTS has also been
approved in select markets abroad, although not widely.
How Supplied:
Testoderm, Testoderm With Adhesive, and Testoderm TTS
transdermal testosterone systems are available in select
human drug markets. Each comes in the form of a transdermal
patch system, which delivers approximately 5 mg of
testosterone each.
Structural Characteristics:
Testoderm® is a matrix-type transdermal drug delivery
system that contains testosterone (free) enclosed in a skinapplied
patch. Testoderm® TTS is reservoir-type
transdermal drug delivery system that contains testosterone
(free) enclosed in a skin-applied adhesive patch. Both are
designed to provide steady but varying levels of testosterone
transdermally during each 24-hour period of application.
Side Effects (Estrogenic):
Testosterone is readily aromatized in the body to estradiol
(estrogen). The aromatase (estrogen synthetase) enzyme is
responsible for this metabolism of testosterone. Elevated
estrogen levels can cause side effects such as increased
water retention, body fat gain, and gynecomastia.
Testosterone is considered a moderately estrogenic steroid.
Exceeding therapeutic doses will increase the likelihood of
estrogenic side effects. In such cases, an anti-estrogen such
as clomiphene citrate or tamoxifen citrate is commonly
applied to prevent estrogenic side effects. One may
alternately use an aromatase inhibitor like Arimidex®
(anastrozole), which more efficiently controls estrogen by
preventing its synthesis. Aromatase inhibitors can be quite
expensive in comparison to anti-estrogens, however, and
may also have negative effects on blood lipids.
Side Effects (Androgenic):
Testosterone is the primary male androgen, responsible for
maintaining secondary male sexual characteristics.
Exceeding therapeutic doses is likely to produce androgenic
side effects including oily skin, acne, and body/facial hair
growth. Men with a genetic predisposition for hair loss
(androgenetic alopecia) may notice accelerated male pattern
balding. Women are warned of the potential virilizing effects
of anabolic/androgenic steroids, especially with a strong
androgen such as testosterone. These may include deepening
of the voice, menstrual irregularities, changes in skin texture,
facial hair growth, and clitoral enlargement.
In androgen-responsive target tissues such as the skin, scalp,
and prostate, the high relative androgenicity of testosterone is
dependant on its reduction to dihydrotestosterone (DHT).
The 5-alpha reductase enzyme is responsible for this
metabolism of testosterone. The concurrent use of a 5-alpha
reductase inhibitor such as finasteride or dutasteride will
interfere with site-specific potentiation of testosterone
action, lowering the tendency of testosterone drugs to
produce androgenic side effects. It is important to remember
that anabolic and androgenic effects are both mediated via
the cytosolic androgen receptor. Complete separation of
testosterone’s anabolic and androgenic properties is not
possible, even with total 5-alpha reductase inhibition.
Side Effects (Hepatotoxicity):
Testosterone does not have hepatotoxic effects; liver toxicity
is unlikely. One study examined the potential for
hepatotoxicity with high doses of testosterone by
administering 400 mg of the hormone per day (2,800 mg per
week) to a group of male subjects. The steroid was taken
orally so that higher peak concentrations would be reached in
hepatic tissues compared to intramuscular injections. The
hormone was given daily for 20 days, and produced no
significant changes in liver enzyme values including serum
albumin, bilirubin, alanine-amino-transferase, and alkaline
phosphatases.593
Side Effects (Cardiovascular):
Anabolic/androgenic steroids can have deleterious effects on
serum cholesterol. This includes a tendency to reduce HDL
(good) cholesterol values and increase LDL (bad)
cholesterol values, which may shift the HDL to LDL balance
in a direction that favors greater risk of arteriosclerosis. The
relative impact of an anabolic/androgenic steroid on serum
lipids is dependant on the dose, route of administration (oral
vs. injectable), type of steroid (aromatizable or nonaromatizable),
and level of resistance to hepatic metabolism.
Anabolic/androgenic steroids may also adversely affect
blood pressure and triglycerides, reduce endothelial
relaxation, and support left ventricular hypertrophy, all
potentially increasing the risk of cardiovascular disease and
myocardial infarction. Therapeutic doses of testosterone
used to correct insufficient androgen production in otherwise
healthy aging men are unlikely to increase atherogenic risk,
and may actually reduce the risk of cardiovascular
mortality.594
To help reduce cardiovascular strain it is advised to
maintain an active cardiovascular exercise program and
minimize the intake of saturated fats, cholesterol, and simple
carbohydrates at all times during active AAS administration.
Supplementing with fish oils (4 grams per day) and a natural
cholesterol/antioxidant formula such as Lipid Stabil or a
product with comparable ingredients is also recommended.
Side Effects (Testosterone Suppression):
All anabolic/androgenic steroids when taken in doses
sufficient to promote muscle gain are expected to suppress
endogenous testosterone production. Testosterone is the
primary male androgen, and offers strong negative feedback
on endogenous testosterone production. Testosterone-based
drugs will, likewise, have a strong effect on the hypothalamic
regulation of natural steroid hormones. Without the
intervention of testosterone-stimulating substances,
testosterone levels should return to normal within 1-4 months
of drug secession. Note that prolonged hypogonadotrophic
hypogonadism can develop secondary to steroid abuse,
necessitating medical intervention.
Administration (General):
Testoderm is applied daily (in the morning) to intact, clean,
shaven dry skin of the scrotum. Testoderm TTS is applied
daily (in the morning) to intact, clean, dry skin of the back,
arms, or upper buttocks. Many OTC ointments will
significantly reduce the penetration of testosterone when
applied to the skin before use, and should be avoided.
Administration (Men):
To treat androgen insufficiency, the prescribing guidelines
for Testoderm and Testoderm TTS recommend the
application of one patch daily, which delivers approximately
5 mg of testosterone systemically. For physique- or
performance-enhancing purposes, higher doses would be
necessary to achieve supraphysiological levels of
testosterone. This would require at least three or four patches
per day, delivering approximately 15-20 mg of testosterone.
This level is sufficient for most users to notice gains in
muscle size and strength, although this is not a very realistic
idea in a practical sense. Lower doses may be used, but
typically when accompanied by other anabolic/androgenic
steroids. Testosterone is ultimately very versatile, and can be
combined with many other anabolic/androgenic steroids to
tailor the desired effect.
Administration (Women):
Testoderm and Testoderm TTS are not FDA-approved for
use in women. Testosterone is not recommended for women
for physique- or performance-enhancing purposes due to its
strong androgenic nature and tendency to produce virilizing
side effects.
Availability:
Given their high relative price and low delivery of
testosterone, Testoderm and Testoderm TTS are not
commonly traded on the black market. Counterfeits have not
yet been reported


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