What Are Pellets?
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.
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 a 'FDA approved' 75 mg testosterone pellet.
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.
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.
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.
- 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.
- 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.
- 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 and men with elevated estrogens, may be treated with the combination testosterone-anastrozole implants.
Will hormone therapy with estradiol and testosterone pellets help with hair loss?
Hormone deficiency is a common cause of hair loss and treatment with testosterone implants can help to re-grow hair. Hair becomes thicker and less dry with pellet therapy.
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.
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.
Do patients need progesterone when they use the pellets?
No. 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 ofsynthetic 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 other health benefits from the hormone, progesterone. It may help with anxiety or insomnia. Interestingly, progesterone implants have been used since the 1940’s.
How are hormones monitored during therapy?
Hormone levels may be drawn and evaluated before therapy is started. This may include an FSH, estradiol, and 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.
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.
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.
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).
Can a patient be allergic to the implants?
Very rarely, a patient will develop local zone of redness (3-8 cm) and itching at the site of the testosterone implant. There is minimal or no tenderness and no other sign of infection. Pellets are made of up testosterone, stearic acid and PVP (povidone). Patients may react to the PVP. Implants can be compounded or made without PVP. Many patients who develop a local reaction to the implant have low cortisol levels and upon further questioning, have symptoms of adrenal insufficiency. Cortisol testing may be recommended. If needed, 25-50 mg of benedryl works well for the itching. See handout ‘Local allergic reaction’ for further recommendations.
Additional information on testosterone implant therapy:
- Safety of Maternal Testosterone therapy during breast feeding IJPC
- How effective is testosterone implant therapy?