Testosterone therapy for men is not new. In fact, pellet therapy for men has been around since the 1930s. Hormone replacement therapy by pellet implantation has been used with great success in the United States, Europe and Australia since 1938 and found to be superior to other methods of hormone delivery (Greenblatt 49, Mishnell 41, Cantrill 84, Stanczyk 88).
In 2008, the FDA gave its blessing to Slate Pharmaceutical’s Testopel, a bioidentical testosterone pellet, designed exclusively for men. As many physicians have discovered the ease and effectiveness of this delivery method for testosterone, it has become increasingly popular for men.
Testosterone is an important hormone. Most men lose testosterone with age. A reported 20 to 40 percent of older men have low testosterone and need testosterone therapy.
Low testosterone is among the most common issues facing the aging male. Low testosterone affects multiple aspects of every man’s life.
Testosterone has been shown to increase muscle mass, bump up energy, relieve depression, increase sense of well-being, relieve anxiety, improve memory, and improve concentration.
Testosterone pellets increase lean body mass (muscle strength, bone density) and decrease fat mass. Men 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 have been associated with low testosterone levels.
For delivering a consistent dose over the long term, pellets are the best option. Pellets deliver consistent, physiologic levels of hormones and avoid the fluctuations of hormone levels seen with other methods of delivery (Greenblatt 49, Thom 81, Cantrill 84 Stanczyk 88).
Hormone replacement therapy with testosterone implants is superior to oral and topical (both the patch and gel) hormone replacement therapy for bone density (Savvas 88, 92, Davis 95, Anderson 97).
A short, simple, painless procedure is done in our office to implant the pellets under the skin. The insertion is a simple in-office procedure and is less painful than drawing blood. We apply local anesthesia and make an incision in the upper hip area, placing the pellet inside. No stitches are necessary – the incision is so small, it can be closed up with a piece of tape. Implantation may sound a bit scary, but it is actually a simple procedure that takes only a few minutes.
Testosterone pellets, like Testopel, are small, 3 mm by 9 mm pellets that contain crystalline testosterone. Implanted under the skin, they slowly release testosterone over the course of three to six months.
These pellets are a long-acting form of testosterone therapy. They deliver a stable, steady dose of testosterone. Pellets typically provide the needed level of hormone for four months.
Testosterone pellet implants release testosterone at a steady rate of 1.3 mg/200 mg implant/day. (Kelleher, S. Testosterone release rate and duration of action of testosterone pellet implant).
Testosterone pellets provide sustained levels of testosterone for at least 4 months and up to 6 months. Implantation of 600-800mgs of pellets achieved optimal results with respect to peak mean testosterone level and duration of effect.
Testosterone pellets were generally well tolerated. (McCullough, AR. A Multi-institutional observational study of testosterone pellets)
Natural testosterone is viewed as the best androgen for substitution in hypogonadal men. Subcutaneous testosterone implants provide the patient, depending on the dose of implants, with normal plasma testosterone for 3-6 months. Administration of testosterone to young individuals has almost no adverse effects. (Gooren LJ, Androgen replacement therapy: present and future.)
There are few and uncommon risks associated with pellet implantation. The occasional infection can occur, or the pellets can be “extruded” and come out of the skin. Both of these are uncommon: less than 0.5% of cases result in infection, while as low as 3% percent of cases result in extrusion.
Not a Risk!
We often hear the concern by our men about the risk of developing prostate cancer by being on testosterone pellet therapy. In a landmark study by Dr. Abraham Morgentaler, Harvard Urologist, it was noted that the men with the highest risk of developing prostate cancer when placed on testosterone therapy had a lower rate of developing prostate cancer than those men at high risk who were not placed on testosterone therapy. Dr. Morgentaler writes “we found that men at high risk for prostate cancer did not seem to suffer any dramatic “explosion” of cancer when treated for a year with testosterone therapy. And when I looked back at my extensive experience of treating men with testosterone therapy, many for ten years or longer, precious few cases of cancer had developed.”
Hormone replacement therapy with pellet implantation has an extremely low incidence of side effects (Cardoza 84, Barlow 86, Ganger 89, Pirwany 02) and high compliance rate (Gambrell 06).
Hormones delivered by the subcutaneous implants bypass the liver, do not affect clotting factors and do not increase the risk of thrombosis (Notelovitz 87, Seed 00).
Testosterone delivered subcutaneously by pellet implant is cardiac protective (Sands 97, Worboys 00).
Testosterone delivered by pellet implantation, does not adversely affect blood pressure, lipid levels, glucose or liver functions (Burger 84, Farish 84, Fletcher 86, Barlow 86, Notelovitz 84, Stanczyk 88, Davis 95, 00, Sands 97, Seed 00,Cravioto 01).
The pellets not only prevent bone loss but also actually increase bone density (Savvas 88, Studd 90, Garnett 91, Savvas 92, Naessen 93, Holland 94, Studd 94, Davis 95, Anderson 97, Seed 00, Panay 00).
Safety of the Procedure
Safety is the most common concern when it comes to testosterone therapy which the majority of the public is unfamiliar with. In 2009, the Journal of Sexual Medicine published a study analyzing the data from multiple studies of pellet therapy as far back as December of 2003 through April of 2008. The study focused on male subjects and found that 86 percent of the patients were satisfied with the improvement of their symptoms and the ease of insertion. No patient that followed post-insertion directions experienced any adverse side effects, such as infection or pellet extrusion.