| Frequently Asked Questions |
Pellets - Hormone Implants FAQ
Reference Articles:
‘Beneficial
effects of testosterone therapy in women’ (Glaser,
Dimitrakakis)
'Low testosterone levels in breast cancer patients'
(Dimitrakakis,
Glaser)
'Testosterone-Anastrozole
Implants in breast cancer survivors'
(Glaser)
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Introduction
Data supports that testosterone implants effectively treat
symptoms in both men and women. Implants, placed under the skin,
consistently release small, physiologic doses of hormones
providing optimal therapy without adverse effects.
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What are Pellets?
Pellets, or implants are made up of hormones (i.e. testosterone)
that are pressed or fused into very small solid cylinders. These
pellets are larger than a grain of rice and smaller than a ‘Tic
Tac'. In the United States, the majority of pellets are made by
compounding pharmacists and delivered in sterile glass vials.
There is an 'FDA approved' 75 mg testosterone pellet.
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Why Pellets?
Pellets deliver consistent, healthy levels of hormones for 3-4
months in women and 4-5 months in men. They avoid the
fluctuations, or ups and downs, of hormone levels seen with every
other method of delivery.
This is important for optimal health and disease
prevention. Pellets do not increase the risk of blood clots
like conventional or synthetic hormone replacement therapy.
In studies, when compared to conventional hormone replacement
therapy, pellets have been shown to be superior for relief
of menopausal symptoms, maintenance of bone density, restoration
of sleep patterns, and improvement in sex drive, libido, sexual
response and performance.
Testosterone delivered by a pellet implant, has been used to treat
migraine and menstrual headaches. It also helps with vaginal
dryness, incontinence, urinary urgency and frequency. In both men
and women, testosterone has been shown to increase energy, relieve
depression, increase sense of well being, relieve anxiety and
improve memory and concentration. Testosterone, delivered by
pellet implant, increases lean body mass (muscle strength, bone
density) and decreases fat mass. Men and women need adequate
levels of testosterone for optimal mental and physical
health and for the prevention of chronic illnesses like
Alzheimer's and Parkinson's disease, which are associated with low
testosterone levels.
Even patients who have failed other types of hormone therapy have
a very high success rate with pellets. There is no other ‘method
of hormone delivery' that is as convenient for the patient as the
implants. Implants have been used in both men and women since the
late 1930's. There is significant data that supports the use of
testosterone implants in both men and women.
Click here for a summary of the data
supporting the use of hormone implants.
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How and where are pellets inserted?
The insertion of
pellets is a simple, relatively painless procedure done under
local anesthesia. The pellets are usually inserted in the lower
abdominal wall or upper buttocks through a small incision, which
is then closed with a skin tape (steri-strip). The experience of
the health care professional matters a great deal, not only in
placing the pellets, but also in determining the correct dosage of
hormones to be used.
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Are there any side effects or complications from the insertion of the pellets?
Complications from the
insertion of pellets include; minor bleeding or bruising,
discoloration of the skin, infection, and the possible extrusion
of the pellet. Other than slight bruising, or discoloration of the
skin, these complications are rare.
Testosterone may cause
a slight increase in facial hair in some women. Testosterone
stimulates the bone marrow and increases the production of red
blood cells. A low testosterone level in older men is a cause of
anemia. Testosterone, delivered by implants or other methods, can
cause an elevation in the red blood cells. If the hemoglobin and
hematocrit (blood count) get too high, a unit of blood may be
donated.
After the insertion of
the implants, vigorous physical activity is avoided for 48 hours
in women and up to 5 to 7 days in men. Early physical activity is
a cause of ‘extrusion', which is a pellet working it's way out.
Antibiotics may be prescribed if a patient is diabetic or has had
a joint replaced. However, this is a ‘clean procedure' and
antibiotics may not be needed.
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Why haven't I heard about Pellets?
You may wonder why you haven't heard of pellets. Pellets are not
patented and have not been marketed in the United States. They
are frequently used in Europe and Australia where
pharmaceutical companies produce pellets. Most of the research on
pellets is out of Europe and Australia. Pellets were frequently
used in the United States from about 1940 through the late 70's
when oral patented estrogens were marketed to the public. In fact,
some of the most exciting data on hormone implants in breast
cancer patients is out of the United States. Even in United
States, there are clinics that specialize in the use of pellet
implants for hormone therapy.
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Do men need hormone therapy?
Testosterone levels begin to decline in men beginning in their
early 30's. Most men maintain adequate levels of testosterone into
their mid 40's to mid 50's, some into their late 70's to early
80's. Men should be tested when they begin to show signs of
testosterone deficiency. Even men in their 30's can be
testosterone deficient and show signs of bone loss, fatigue,
depression, erectile dysfunction, difficulty sleeping and mental
decline. Most men need to be tested around 50 years of age. It is
never too late to benefit from hormone therapy.
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What if my primary care physician or my gynecologist says that there is ‘no data' to support the use of pellet implants?
He or she is wrong. There is a big difference between ‘no data'
and not having read the data. It is much easier for busy
practitioners to dismiss the patient, than it is to question their
beliefs and do the research. It's about a patient making an
informed choice. After testosterone pellets are inserted, patients
may notice that they have more energy, sleep better and feel
happier. Muscle mass and bone density will increase while fatty
tissue decreases. Patients may notice increased strength,
co-ordination and physical performance. They may see an
improvement in skin tone and hair texture. Concentration and
memory may improve as will overall physical and sexual health.
There is also data to support the ‘long term' safety of
testosterone delivered by pellet implants.
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Do pellets have the same danger of breast cancer as other forms of hormone replacement therapy?
Testosterone , delivered by pellet
implantation, has been shown to decrease breast proliferation and
lower the risk of breast cancer, even in patients on
conventional hormone replacement therapy. Clinical studies show
that testosterone balances estrogen and is breast protective. In
the past, testosterone implants have been used to treat patients
with advanced breast cancer. In 1940, it was theorized that
treating patients with testosterone implants earlier, at the time
of diagnosis, would have an even greater benefit, preventing
recurrent disease. Androgens have also been shown to enhance the
effect of Tamoxifen® therapy in breast cancer patients. References
supporting these statements can be found in the
data section
of the website in the ‘Breast Cancer Folder'.
In contrast to testosterone,
Estradiol, whether
delivered by pellet implant*, applied topically to the skin or
taken orally has been
shown to increase the risk of breast cancer.
This is not surprising, as continuous Estradiol, a strong
estrogen, has been shown to stimulate breast tissue.
*Million Women’s Study
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Are there other hormones besides
testosterone that have not been shown to increase the risk of
breast cancer?
Bio-identical
progesterone (including FDA approved Prometrium®) has not been
shown to increase the risk of breast cancer like the synthetic
progestins. In addition, progesterone, used vaginally, does not
negate the beneficial effects of estrogen on the heart like the
synthetic progestins.
Estriol is a
bio-identical estrogen widely used in Europe that does not bind
strongly to estrogen receptor and does not stimulate breast
tissue. Numerous studies have shown that
vaginal estriol does
not increase the risk of breast cancer (RR 0.7). It has safely
been used in breast cancer survivors.
However, higher doses of vaginal estradiol (> 25 mcg) and
vaginal Premarin® provide systemic levels of strong estrogens that
may stimulate breast tissue.
If you are a breast cancer survivor, it is important that
your physician understands this.
Balanced hormones are the key to health and disease
prevention.
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Why
isn’t estrogen therapy or Estradiol pellet therapy recommended?
We have shown that symptoms, including hot flashes, are relieved
with continuous testosterone alone.
Testosterone delivered by pellet implant is extremely
effective therapy.
In addition, it does not have the unwanted side effects
of estrogen therapy.
Over
half of women treated with estrogen (especially the pellet
implant) will experience uterine bleeding. If a
menopausal patient has bleeding, she must notify her physician and
have an evaluation, which may include a vaginal ultrasound and
endometrial biopsy.
Estrogen also stimulates the breast tissue can cause breast
pain and cysts. It
also increases the risk of
breast cancer.
Higher levels of estrogen (in the second half of the menstrual
cycle) are needed for pregnancy.
Most women feel better with lower levels of estrogen.
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Almost
all symptoms, including hot flashes, are relieved with
testosterone pellets alone. A study by Sherwin in 1985 looked
at testosterone, testosterone with estradiol, estradiol alone
and placebo. The group of women who responded best (somatic,
psychological and total score)…testosterone alone! The groups
that did the worst…estrogen alone and placebo. Higher levels
of testosterone were associated with a better response. These
results are expected.
Testosterone is
the major ‘substrate’ for estrogen production in the brain,
bones, vascular system, breast and adipose tissue. Some
physicians do not understand this and may insist that estrogen
therapy is needed.
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Excess estrogen
can cause anxiety,
weight gain, belly fat, tender breasts, emotional lability,
symptoms of PMS, and mood swings. Long-term exposure to
stronger estrogens like estradiol and Premarin can increase
the risk of breast cancer. In addition, there is exposure to
many estrogen-like chemicals.
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Some women (and men) ‘aromatize’ or convert
too much testosterone to estradiol, which can interfere with
the beneficial effects of testosterone. An ‘aromatase
inhibitor’ (i.e. anastrozole) may be prescribed to prevent
this. Patients, including breast cancer survivors, may be
treated with the combination
testosterone-anastrozole implants.
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Will hormone therapy with estradiol and testosterone pellets help with hair loss?
Hormone deficiency is a common cause of hair loss and treatment
with estradiol and testosterone implants can help to re-grow hair.
Hair becomes thicker and less dry with pellet therapy.
Click here for more information ‘Hair Health
and Hormone Balance'
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How long until a patient feels better after pellets are inserted?
Some patients begin to ‘feel better' within 24-48 hours while
others may take a week or two to notice a difference. Diet and
lifestyle, along with hormone balance are critical for optimal
health. Stress is a major contributor to hormone imbalance and
illness. Side effects
and adverse drug events from prescription medications can
interfere with the beneficial effects of the testosterone implant.
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How long do pellets last?
The pellets usually last between 3-4 months in women and 4-5
months in men. The pellets do not need to be removed. They
completely dissolve on their own.
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Do patients need progesterone when they use the pellets?
Women who are treated
with testosterone implants alone (no estrogen therapy) do not
require progestin therapy.
However, if estradiol,
or other estrogen therapy is prescribed, progestins are also
needed. The main indication for the use of synthetic
progestins, like Provera® or progesterone, is to prevent the
proliferation (stimulation) of the uterine lining caused by
estrogen. Progestin
therapy is NOT required if estrogen therapy is not prescribed.
However, there may be health benefits to the hormone,
progesterone.
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How are hormones monitored during therapy?
Hormone levels may be
drawn and evaluated before therapy is started. This may include an
FSH, estradiol, testosterone (free and total) for women. Men need
a PSA (prostate specific antigen), sensitive estradiol,
testosterone, LH, liver profile and blood count prior to starting
therapy. Thyroid hormone levels (TSH) may also be evaluated.
In men, follow up
levels, including a PSA, blood count and estradiol, may be
obtained prior to subsequent testosterone implantation. Men must
notify their primary care physician and obtain a digital rectal
exam each year. Women are advised to continue their monthly
self-breast exam and obtain a mammogram and/or pap smear as
advised by their gynecologist or primary care physician.
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How much does this cost?
The cost for the
insertion of pellets is between $230 and $500 depending on the
dose of the hormone and the number of pellets needed. Men need a
much larger dose of testosterone than women and the cost is
higher. Pellets need to be inserted 2 to 4 times a year depending
on how rapidly a patient metabolizes hormones.
When compared to the
cost of drugs to treat the individual symptoms of hormone decline,
pellets are very cost effective.
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Will insurance cover the procedure?
Some insurance companies cover the cost of pellets, especially in
men. Others do not. Most physicians require payment for their
services. Patients may want to contact their insurance companies
to see if their costs will be reimbursed. Prevention is much more
cost effective than disease.
Patients are able to ‘appeal' a denied
claim.
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Is there a role for testosterone implants (pellets) in a pre-menopausal female?
Testosterone pellets may be used in pre-menopausal females (women
who have not stopped menstruating). Testosterone has been shown to
relieve migraine or menstrual headaches, help with symptoms of PMS
(pre menstrual syndrome), relieve anxiety and depression, increase
energy, help with sleep and improve sex drive and libido. If a
pre-menopausal female has a testosterone pellet inserted, she must
use birth control. There is a theoretical risk of ‘masculinizing’
a female fetus (giving male traits to a female fetus).
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