The patient guide to pellet therapy
Hormone therapy is considered the most effective treatment for symptoms of Menopause and Andropause. In the interest of a straightforward approach to hormone therapy, Natural Hormone Therapy has become widely used. These are hormones that are identical in molecular structure to the hormones made in the human body, which is thought to provide improved absorption. They are made from a plant chemical extracted from yams and soy, and act in the body just like the natural hormones our body naturally produces.
The implants are small cylindrical pellets created in a compounding pharmacy that are made in many different formulations and doses customized for the needs of the patient. Pellet therapy is a safe and effective method for delivering needed medications in small doses consistently over time. Pellet therapy can be a convenient choice for achieving balance in Natural Hormone Therapy.
Hormone replacement therapy by pellet implantation has been used in the United States, Europe and Australia for more than 75 years. Research has shown pellet implantation therapy to be superior to other methods of hormone delivery because it delivers small, physiologic doses of medication consistently over time. Also, unlike oral methods, the pellet delivery system bypasses the liver, which is shown to not negatively impact clotting factors, blood pressure, lipid levels, glucose, or liver function.
PELLET IMPLANTS MAY IMPROVE
Before starting any hormone replacement therapy, patients should work directly with a knowledgeable healthcare practitioner for a combined evaluation of the patient’s current hormone levels (through blood or saliva testing) and personal health history profile. Based on existing hormone levels and health history, the practitioner will make a hormone replacement recommendation. Once pellets have been inserted, hormone levels will be reevaluated prior to the insertion of the next round of pellets. After the first year of therapy, the practitioner may suggest testing less frequently based upon patient feedback and prior hormone levels.
Pellet Implants require a consultation and a prescription from your healthcare practitioner. Once you are evaluated and lab values are reviewed, your practitioner will help you decide the best method for therapy. Pellet implants are usually made by a compounding pharmacy.
Pellet insertion is an outpatient procedure done in your practitioner’s office. A local anesthetic is used to numb the area, usually the hips or buttocks, and the pellets are inserted through a very small incision under the fatty layer of skin. The incision is then closed with sterile-tape strips. You should not be able to feel the implants under the skin. Minimal bruising or no tenderness should be expected. However, any side effects should be discussed with your practitioner. After the pellet procedure, vigorous activity should be avoided for 2-3 days, or as suggested by your health care practitioner.
In most patients, pellet implants last between 3-6 months. The dissolution time is based upon how rapidly the patient metabolizes hormones. Patients can experience the effect of the therapy in as little as 2 days, however it can take up to 2 weeks to experience symptom relief. The pellets do not need to be removed, as the body absorbs them completely over time.
The cost for pellet therapy varies based on your individualized plan. The dosage required to achieve balance will be based upon your complete blood count, your healthcare practitioner will determine the type and number of pellets required. The frequency of pellet insertion will depend on how your body metabolizes hormones. In most cases hormone implants will last between 3 and 6 months. In comparison to traditional pharmaceutical prescriptions, the cost of pellet therapy for Natural hormone therapy is cost effective.
Most insurance companies reimburse for outpatient procedures. Some insurance companies will cover the cost of pellets. The best way to ensure accurate information about your specific insurance coverage is to call the carrier directly and inquire about the procedure. The procedure code (or CPT) is 11980, Subcutaneous Hormone Pellet Implantation; the drug code (or HCPCS) would be J3490 Unclassified drugs [when specified as estrogen or estrogen/testosterone pellets]. Your physician will need to provide applicable diagnosis codes (or ICD-9) based on your evaluation to share with your insurance company.
The pellet implants are not considered a FDA approved drug. However, this does not mean that they are not considered safe. The process to seek FDA approval for a drug is lengthy and very expensive. Because the compounds used to make the pellets are natural, and therefore not patentable, drug companies are not interested in manufacturing them nor going to the expense of having them approved.
Our licensed facilities, in which the pellets are produced, are compliant with USP-797 and ISO-Class 5 clean room regulations, exceeding the standards required for sterilization and quality. The pharmacies employ non-bias testing from independently registered FDA testing labs to promise sterility and potency with each and every pellet batch produced. Ensuring physicians and patients high quality, consistent pellet implant products.
The term "Menopause" is commonly used to describe the changes a woman experiences either just before or after she stops menstruating, marking the end of her reproductive period. Menopause is considered a natural element of aging and usually occurs after the age of 40. However, some women can go through menopause early, either as a result of a hysterectomy, damage to the ovaries, or chemotherapy. For many women symptoms of menopause can begin occurring up to 8 years prior to the cessation of menstruation.
Estrogen is a hormone that fluctuates over the course of a woman’s menstrual cycle. During peri-menopause, a woman's body produces less estrogen and progesterone. Progesterone is a steroid hormone that works with Estrogen to regulate the inner lining of the uterus. The fluctuation of estrogen levels and progesterone may decline at menopause and can cause uncomfortable symptoms:
PRIMARY MENOPAUSE SYMPTOMS
Falling estrogen levels are often accompanied by androgen decline and can lead to decreased sexual desire. The ovaries and adrenal glands secrete androgen, primarily as testosterone. Testosterone therapy may be indicated for postmenopausal women with symptoms of decreased sexual desire.
Natural Hormone Therapy can relieve symptoms of Menopause, help improve vitality, and restore health. An individualized approach to natural hormone therapy determines your exact hormone levels, and what is needed to balance your deficiencies.
Hormone therapy is considered the most effective treatment for symptoms of Menopause and Andropause. In the interest of a straightforward approach to hormone therapy, Natural Hormone Therapy has become widely used. These are hormones that are identical in molecular structure to the hormones made in the human body, which is though to provide improved absorption. They are made from a plant chemical extracted from yams and soy, and art in the body just like the natural hormones our body naturally produces.
Before starting any hormone replacement therapy, patients should work directly with a knowledgeable healthcare practitioner. The practitioner will measure hormones through blood or saliva testing and evaluate your personal health profile. Based on existing hormone levels and health history, the practitioner will make a hormone replacement recommendation.
Oral pharmaceuticals, transdermal (skin) creams, and intramuscular injections are available options but require daily or weekly application and can cause peaks and troughs. Most women are good candidates for hormone pellets. These pellets are long-acting, deliver a stable, steady dose of hormones consistently over a period of 3 to 6 months, and have been shown to have many benefits.
Once you begin your pellet therapy, you should start feeling the effects within a few weeks. Lab tests will be ordered occasionally to determine the effect of the therapy on your hormone levels. Once balanced, most patients feel an improved sense of well-being, better mood, more energy, and improved quality of life.
Estrogen therapy has been shown to maintain the mineral content and strength of bones after menopause. The consistent levels of estrogen achieved by the pellets are especially effective in preventing bone loss.
Without hormone balance, estrogen decline may increase risk for premature Alzheimer’s disease, colon cancer, diabetes, heart disease, ovary failure, osteoporosis, and Parkinson’s disease. The longer a woman is without the protection of estrogen, the greater the risk for the decline of her health and vitality.
Oral estrogen is metabolized in the liver, which has been shown to increase the risk of blood clots, strokes, and heart attacks. The estrogens in pellets are absorbed directly into the blood stream, which is not known to increase any of these risk factors.
Testosterone is a male sex hormone that is important for sexual and reproductive development. It affects libido (sexual desire) as well as the ability to have sex (establish and maintain an erection). It is also important in maintaining strong bones, skin elasticity, muscle mass, heart function, and mood. The National Institute of Health regards testosterone as the most important male hormone. Women also produce testosterone, but at lower levels than men.
Andropause is sometimes referred to as male menopause. Most men’s testosterone levels peak around 35 and start to decline slowly at the rate of 1 to 2% per year. Most men experience a slow decline, and by age 50 begin to notice that they are not experiencing the same energy and vitality they once enjoyed. Unlike menopause, which usually happens within a 6-12 month period for women, Andropause occurs slowly and insidiously over many years.
Men do not have to accept the effects of hormone decline. Natural hormone therapy can help by allowing you to feel and perform at the same levels as when you were much younger. An individualized approach to hormone replacement therapy determines your exact hormone levels, and what is needed to balance your deficiencies. The differences between synthetic and Natural Hormone Therapy is that natural hormones share the same chemical structure as the hormones created naturally in the body. The molecule shape, make-up, and structure is identical to what is made in the human body to provide the perfect “key” to unlock the body’s receptor sites. Synthetic hormones, on the other hand, have been synthesized in a pharmaceutical laboratory out of chemical compounds, which would have a molecular bond not recognized by the human body, and therefore are not metabolized the same as a natural substance.
ADAM (ANDROGEN DEFICIENCY OF THE AGING MALE) TEST FOR TESTOSTERONE DEFICIENCY
YOU MAY HAVE A TESTOSTERONE DEFICIENCY IF
Intramuscular injections and transdermal (skin) applications of a cream or gel are readily available but require daily or weekly application and can cause peaks and troughs. Most men are eligible candidates for testosterone pellets that are inserted subcutaneously (under the fatty lining of skin), either in the lower abdomen or the upper buttocks through a very small incision. Pellet insertion is a simple in-office procedure done using local anesthesia. The implants placed under the skin are a long-acting, delivering a stable, steady dose of testosterone consistently over 3 to 6 months. This form of Testosterone replacement has been shown to have many benefits.
Generally, there are minimal side effects associated with the testosterone pellet implant. Complications of the procedure can include: minor bleeding, bruising, infection, and pellet extrusion. Other than slight bruising, complications are very rare. Hormone side effects vary per individual and should be discussed by your healthcare practitioner.
Once you begin your testosterone therapy, you should start feeling the effects within a few weeks. Blood tests will be ordered regularly to determine the effect of the therapy on your testosterone level. Once balanced, most men feel an improved sense of well-being, better mood, more energy, improved sexual desire and performance, and a reduction in aches and pains.
BENEFITS OF TESTOSTERONE PELLET THERAPY MAY INCLUDE
HORMONAL PROFILES IN POSTMENOPAUSAL WOMEN AFTER THERAPY WITH SUBCUTANEOUS IMPLANTS
Margaret H. Thom, W. P. Collins and J. W. W. Studd, BJOG: An International Journal of Obstetrics & Gynecology, Volume 88, Issue 4, pages 426–433, April 1981
Plasma hormones were estimated in 24 postmenopausal patients who had been castrated. Each was given a sub-cutaneous implant of either 100 mg or 50 mg of oestradiol, or 50 mg of oestradiol with 100 mg of testosterone, or 200 mg of testosterone. These values compare favorably with those attained after oral estrogen therapy.
PHARMACOKINETICS AND PHARMACODYNAMICS OF TESTOSTERONE PELLETS IN MAN
David J. Handelsman, Ann J. Conway, and Lyn M. Boylan, The Journal of Clinical Endocrinology & Metabolism, Volume 71, Issue 1, October 23, 1989
We studied the pharmacokinetics and pharmacodynamics of implanted pellets of fused crystalline testosterone. We conclude that fused pellets of crystalline testosterone provide very satisfactory depot androgen replacement exhibiting many desirable features for androgen replacement.
SUBCUTANEOUS HORMONE IMPLANTS FOR THE CONTROL OF CLIMACTERIC SYMPTOMS: A PROSPECTIVE STUDY
M. Brincat, J.W.W. Studd, T. O'Dowd, A. Magos, L.D. Cardozo, P.J. Wardle, D. Cooper. The Lancet Volume 323, Issue 8367, 7 January 1984, Pages 16–18. Originally published as Volume 1, Issue 8367
The statistically highly significant levels of symptom relief that followed an oestradiol and testoserone implant were contrasted sharply with the lack of any significant relief with placebo. Despite the success of oestradiol and testosterone implants in relieving symptoms of the climacteric, symptoms returned once the treatment was stopped.
TESTOSTERONE RELEASE RATE AND DURATION OF ACTION OF TESTOSTERONE PELLET IMPLANTS
S. Kelleher, C. Howe, A. J. Conway and D. J. Handelsman. Clinical Endocrinology, Volume 60, Issue 4, pages 420–428, April 2004
Testosterone pellet implants release testosterone at a steady rate of 1·3 mg/200 mg implant/day (95% CI). The duration of action is about 6 months in an uncomplicated cycle with timing of return shortened by extrusions only in the 3·6% of procedures followed by multiple extrusions.
BONE MINERAL DENSITY OUTCOMES FOLLOWING LONG-TERM TREATMENT WITH SUBCUTANEOUS TESTOSTERONE PELLET IMPLANTS IN MALE HYPOGONADISM
Margaret R. Zacharin, Joseph Pua and Shankar Kanumakala. Clinical Endocrinology, Volume 58, Issue 6, pages 691–695, June 2003
Long-acting subcutaneous testosterone pellet implants as replacement therapy in male hypogonadism are safe, acceptable to the patient, result in adequate bone mass accumulation and maintenance of normal bone mineral density.
AN ANALYSIS OF TESTOSTERONE IMPLANTS FOR ANDROGEN REPLACEMENT THERAPY
David J. Handelsman, Mary-Anne Mackey, Chris Howe, Leo Turner and Ann J. Conway, Clinical Endocrinology, Volume 47, Issue 3, pages 311–316, September 1997
This study demonstrates the very satisfactory clinical acceptability of testosterone pellet implants for androgen replacement therapy within a single unit with experienced operators.
A COMPREHENSIVE REVIEW OF THE SAFETY AND EFFICACY OF BIOIDENTICAL HORMONES FOR THE MANAGEMENT OF MENOPAUSE AND RELATED HEALTH RISKS
B Hormones - Altern Med Rev, 2006, D. Moskowitz