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Testosterone Pellet Therapy

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Testosterone Pellet Therapy

A convenient replacement option that eliminates the need for self-administration
pellet sizes

Pellets offer a valuable treatment option for patients who prefer not to self-administer.

In pellet therapy, pellets about the size of a grain of rice are implanted under the skin by a medical professional while in the Defy Medical clinic. The pellets deliver a steady dose of testosterone over a period of 3 to 6 months and are absorbed into the body (no need for removal).

Patients receive new pellet implants every three to four months. Follow-up blood work and examinations will be done during the same appointment to reduce the need for additional visits to the clinic.

How to Become a Patient
All new patients follow these steps:
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Complete initial assessment, history, and condition

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Blood work panel that includes the following tests and important biomarkers:

  • Comprehensive Metabolic Panel 
  • CBC 
  • Lipid Panel 
  • Testosterone Free and Total 
  • Estradiol Sensitive 
  • DHEA-S 
  • TSH 
  • PSA 
  • LH 
  • Sex Hormone Binding Globulin 
  • IGF-1
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Physical Examination

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Consultation with your Defy Medical physician

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If you and your provider decide pellets are the best option for you, the first dose will be inserted immediately after your consultation

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Regular follow-up evaluations and ongoing physician support

Active patients with current lab results on file can schedule an interim consultation to discuss this option, or wait to discuss at their regularly scheduled appointment. 

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Pellet Therapy Costs

Female

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Initial consultation: $250
Initial lab work: $235
Insertion: $350 (Includes pre-insertion consultation appointment after the initial consultation) consultation)
Three-to-four-month follow-up lab work: $106
6-month follow-up lab work: $193

Male

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Initial consultation: $250
Initial lab work: $279
Insertion: $595 (Includes pre-insertion consultation appointment after the initial consultation) consultation)
Three-to-four-month follow-up lab work: $142
6-month Follow-up lab work: $237

Pellet Therapy Appointments

● Patients average 3 - 4 insertions per year (every 3 - 4 months.) Insertions are done at Defy Medical’s Tampa clinic and typically take less than 15 minutes.

● To find the right balance for you and keep you dialed in, Defy requires blood work with a lab review consultation every 6 months. Patients can choose to schedule consultations conveniently over the phone or as part of an extended appointment that includes pellet insertion. These consultations are typically up to an hour and give you an opportunity to ask questions and get an in-depth understanding of your progress.

● As part of your comprehensive care, an annual physical examination is required. Physical examinations will be completed conveniently at the Defy Medical clinic during the your pellet insertion appointment.

Take a tour of Defy Medical’s Tampa location

Pellet Therapy FAQs

Pellet hormone therapy is typically used to treat hypogonadism or low testosterone in men and women.

Available strengths include: 25mg, 50mg, 100mg, and 200mg

A sterile pellet containing testosterone is a novel dosage form that provides another convenient option for patients receiving testosterone replacement therapy. Testosterone administration by pellet allows for less frequent administration than other forms of testosterone. Testosterone pellets have grown in popularity due to their convenience and cost effectiveness.

Implantable pellets deliver testosterone over a longer duration than most other common dosage forms. Six (or four) 200mg pellets can provide stable, effective and well-tolerated testosterone replacement for three to four months, depending on the patient. Plasma testosterone levels peak at the end of the first month, and levels return to base line at the end of month 7. In most patients, inserting pellets every three to four months will maintain testosterone levels without a significant decline.

Once inserted under the skin, each pellet delivers a steady dose of testosterone into the bloodstream over a period of 3 - 6 months. This timed release helps to increase testosterone levels to a target range gradually over a longer period than testosterone injections*. Most patients experience a significant decline of testosterone levels after 3 months.

*Testosterone undecanoate as AVEED® is a more recent FDA-approved injection that has a longer half-life that is comparable to testosterone pellets (less than 30 days).

The insertion of pellets is a relatively simple procedure performed under local anesthesia and by a trained medical doctor or mid-level practitioner.

The pellets are implanted in the subcutaneous tissue of the hip and buttock area under sterile conditions. By making a small incision, the pellet is inserted beneath the fatty lining of the skin. Once the pellet has been properly encapsulated in the body, it is then closed with surgical glue or sterile medical tape strips.

Implants placed under the skin provide the consistent release of small, physiologic hormone doses that have been shown to provide the benefits of hormone replacement therapy.

Testosterone pellets are usually administered every three to four months with patients averaging three to four visits per year. Follow-up reviews can be scheduled during the same appointment as the pellet insertion or completed over the phone using our telemedicine service, therefore eliminating the need for additional office visits.

Pellet insertion should take less than 15 minutes. Additional time may be needed to complete scheduled examinations or consultations, but Defy Medical providers do their best to keep the appointment time minimal while ensuring the patient does not feel rushed.

Pellet implantation is a painless procedure that only takes a few minutes to complete. A trained physician will insert the prescribed number of pellets under the skin using a device called a trochar. The area will be thoroughly anesthetized prior to the implantation. No stitches are necessary.

There is minimal recovery that can sometimes include mild soreness and/or bruising at the insertion site. Patients can quickly resume normal activity at the discretion of the physician.

Patients are given enough pellets to increase testosterone to physiological levels.

In patients who are new to pellet therapy, some dose adjustments might occur during the initial insertion. Depending on the patient’s size, goals, and response to the pellets, your Defy provider may implant four to 12 pellets in men or one to four pellets in women.

The amount also depends on the pellet dose size. Bloodwork and a review of symptoms will help the doctor determine how many pellets to insert. The doctor will make necessary adjustments at each follow up.

If a patient does not receive enough pellets during a previous insertion, an additional testosterone injection may be offered to maintain adequate testosterone levels until the next insertion.

All patients receive affordable access to medications used to support testosterone replacement therapy and sexual health. HCG, FSH, Tri-Mix, PDE5 inhibitors and other medications can be shipped directly to the patient, if necessary, using the Defy Medical portal.

Pellets are a great option for patients who travel or who have a busy schedule. Schedule your appointments ahead of time or at the last minute. The Defy Medical clinic maintains a flexible schedule with extended hours to accommodate busy patients. We also offer several ways to conveniently schedule your appointment with no phone call necessary.

On average, patients complete two follow-up consultations per year. All consultations are performed by a Defy Medical provider (MD, DO, NP, PA) who is part of the patient’s dedicated care team. Any additional questions or issues can be addressed during the consultations.

Lab review consultations can be done over the phone to reduce the need to visit the clinic. Consultations can also be scheduled on the same day as the pellet insertion.

Bloodwork is ordered a minimum of twice per year and can be completed at the clinic during your follow-up appointment or at a local patient service center located near your home or work.

Regular blood work helps your provider determine the number of pellets to insert. It also gives your provider an opportunity to review markers that are important to monitor while undergoing testosterone replacement therapy. Your care team will review your results with you during follow-up consultations.

Each patient has a dedicated care team who is available to assist with any questions or concerns. Patients have access to our telemedicine service available Monday through Saturday with extended hours during weekdays. Whether it’s a new health concern or a question related to a treatment, our team looks forward to assisting. Contact Defy Medical today for immediate assistance.

Prior to starting any form of HRT, Defy Medical requires comprehensive hormone lab testing to evaluate each patient’s overall health and individual hormone levels.

This blood work is assessed along with symptoms, medical history, and a recent physical examination. This allows the medical staff to customize an individualized treatment plan for you based around your unique needs, levels, and goals.

Patients can choose to have the blood work completed at our Tampa clinic, or request a lab order which they can have completed at one of our affiliate labs.

If pellets are the right treatment for you, the prescribed dosage and follow-up schedule will be determined during the initial evaluation with one of our medical practitioners. Thereafter, the pellet insertion procedure will be performed by a trained medical provider.

More Information About Testosterone Pellets
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Defy Medical’s Pellet Source

Defy Medical only uses sterile pellets that are manufactured in an FDA-registered facility with cGMP quality standards. Each pellet receives gamma radiation for sterilization and every batch is tested by a third-party analytical lab for sterility, potency, and endotoxins, before being dispensed for insertion. Our pellets are designed to be resistant to breakage and are capsule shaped for easier insertion. All hormone pellets are compounded PVP-free, for patients sensitive to these binders.

Testosterone pellets are available in four strengths. The dose sizes are 25mg, 50mg, 100mg, and 200mg. Each dose size has been designed and engineered to ensure the same active-to-inactive ingredient ratio across the dose size range. Each testosterone pellet contains only one inactive ingredient (Stearic Acid), eliminating the need for a polymer to be implanted into a patient's body.

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Testosterone pellet manufacturing highlights:

  • Pellets’ capsule shape is resistant to breakage 
  • Consistent color and texture 
  • FDA Registered 503B Outsourcing Facility 
  • Third party potency and sterility tested 
  • Sterilized with validated E-beam irradiation process 
  • PVP free, for patients sensitive to these binders 
  • Manufactured in a dedicated cGMP & USP 800 compliant cleanroom
Read more about our testosterone pellet manufacturer
Summary of Data

Search the following keywords to discover more research regarding testosterone pellets:

Testosterone Pellets; Hormone pellets; Testosterone implants; Hormone implants; Testopel®; Subcutaneous pellets; Subdermal pellets; implantable pellets; implantable pellet dosage form

Andrew McCullough

CONCLUSION: The use of T implants (pellets) as a form of T replacement has been reported since 1938 [19]. The formulation approved by the FDA in 1972 was Testopel®. Despite a lack of information provided by the package insert, there is a wealth of information available through peer-reviewed studies on similar preparations and the product itself. Pellets provide sustained eugonadal T levels for 3–6 months. Contemporary studies suggest that the FDA recommended 3–6 pellets are inadequate for most men and that 10 pellets (750 mg) produce the most reliable levels. Post implantation levels are affected by the volume of distribution, i.e., thin men require fewer, whereas morbidly obese men might require more. Extrusion and implantation infection rates at high-volume centers with Testopel® are less than 1 %, and patient acceptance of the procedure is very high. As with all forms of replacement therapy, close monitoring of therapeutic efficacy is important. More long-term studies on clinical efficacy and safety are needed.

ALEXANDER W. PASTUSZAK,* HARSHA MITTAKANTI,JOCELINE S. LIU,LISSETTE GOMEZ,LARRY I. LIPSHULTZ,* AND MOHIT KHERA*

ABSTRACT: Subcutaneous testosterone (T) pellets are a viable treatment modality for hypogonadism. Optimal dosing, frequency of reimplantation, and long-term safety of T pellets remain incompletely elucidated parameters. A retrospective review of 273 patients treated for hypogonadism using subcutaneous T pellets was performed. Serum total T (TT), free T (FT), and estradiol (E2) levels were analyzed as a function of time from implantation, number of pellets implanted (6–9 or 10–12), body mass index (BMI; ,25 or 25 kg/m2), number of implantations (#4 rounds, 501 insertions), and preimplantation T levels (,300 or 300 ng/dL). T decay was determined using linear regression and TT levels immediately postimplantation and the time for TT levels to reach 300 ng/dL extrapolated for all variables. Mean patient age 6 SD was 56 6 12.6 years. Baseline TT level was 328 6 202 ng/dL, FT 9.49 6 27.8 pg/mL, and E2 25.1 6 17.3 pg/mL. Extrapolated TT and FT peaks were lower in men receiving 6 to 9 pellets than men receiving 10 to 12, although decay rates differed insignificantly. E2 levels rose significantly in men receiving 10 to 12 but not 6 to 9 pellets. Men with BMI $25 kg/m2 attained lower TT peaks with slower decay than men with BMI ,25 kg/m2 receiving 10 to 12 pellets, although 300 ng/dL TT levels were reached at approximately 100 days in both groups. No differences were seen in decay rates for men with multiple implant rounds, and no differences in T peaks or decay rates were seen in men with preimplant T level ,300 or 300 ng/dL. One patient developed erythrocytosis, and no prostate-specific antigen recurrences were observed in men with prostate cancer treated with T pellets. Men with BMI ,25 kg/m2 should receive fewer pellets, and reimplantation for all men should occur 100 to 120 days after prior implantation. Men receiving 10 to 12 pellets have higher E2 levels, potentially reflecting increased aromatization of T. Reimplantation and preimplantation TT levels do not affect pellet decay kinetics.Key words: Testosterone replacement, testosterone implant, Hypogonadism.

J Androl 2012;33:927–937

Pastuszak AW, Gomez LP, Scovell JM, Khera M, Lamb DJ, and Lipshultz LI.

Introduction: Numerous testosterone (T) formulations are available, each with differing effects on serum parameters.

Aim: The aim of this study was to compare the long-term effects of topical, injectable, and implantable pellet T formulations in hypogonadal men.

Methods: Retrospective review of hypogonadal men treated with a single T formulation was performed: 47 men on T gels, 57 on injectable T, and 74 on T pellets were identified. Total T (TT), calculated free T (FT), estradiol (E), hemoglobin (Hgb), hematocrit (Hct), prostate-specific antigen (PSA), total cholesterol (Tchol), triglycerides (TG), low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol were evaluated at baseline and every 3–6 months for 3 years. Serum parameters were compared using a mixed model linear regression for repeated measures.

Main Outcome Measures: Effects of topical, injectable, and pellet T formulations on serum hormone levels, Hgb, Hct, lipid parameters and PSA.

Results: Menin the injectable T group were younger (42.5 ± 12.3 years) than in the gel (54.1 ± 9.8 years) or pellet groups (53.8 ± 13.0 years), and baseline FT, Hgb, and Hct were higher in the injectable T group than in gel or pellet groups. Increases in TT and FT were observed throughout follow-up in all groups. Increases in E were observed at in all T groups and throughout follow-up in injectable and gel groups.NoPSAincreases were observed. Erythrocytosis (Hct > 50%) was more common with injectable T (66.7%) than with T gels (12.8%) or pellets (35.1%, P < 0.0001). Transient changes in cholesterol, TG, and LDL were observed, and no significant changes were seen in HDL for any group.

Conclusions: All T formulations increase serum T and FT. More significant increases in E occur with injectable T and T gels. Changes in Hgb and Hct are most significant with injectable T, and effects on lipids are variable and inconsistent. Selection of T formulations must account for individual patient preferences and the effects of each formulation.

antigen. Sex Med 2015;3:165–173.

Kaminetsky JC1, Moclair B, Hemani M, Sand M.

INTRODUCTION: Men with hypogonadism exhibit decreased serum testosterone levels and may experience a constellation of clinical symptoms, including decrease in muscle mass, loss of sexual desire, impotence, and infertility. While previous studies have shown that implantation of extended release testosterone pellets can provide therapeutic levels of testosterone over several months, additional data are needed to establish this approach as the standard of care for male hypogonadism.

AIM: To evaluate the safety and efficacy of testosterone pellets over 6 months as a treatment for male hypogonadism in a clinical practice setting.

METHODS: A phase IV, single center, open-label study designed to assess the safety and efficacy of subcutaneous insertion of 8 to 12 testosterone 75 mg pellets (450 mg to 900 mg), during a single implantation procedure in hypogonadal men. Subjects who successfully completed the protocol were allowed to enroll in an extension study that included another implantation and 6 months of follow-up.

MAIN OUTCOME MEASURES: Safety was determined by investigator-reported adverse events, changes in vital signs, physical exam findings, and laboratory tests. Efficacy was based on serum laboratory tests, physical exams, implantation site evaluations, and vital signs. Secondary objectives were to assess patient preference for testosterone pellets and to maintain optimal total testosterone.

RESULTS: Mean testosterone significantly increased and luteinizing hormone (LH) levels significantly decreased from pre-implantation values at weeks 1, 4, and 12, and had returned to pre-implantation levels by week 24. Prostate-specific antigen levels remained unchanged for the duration of the study. Improvements in several symptoms of hypogonadism were determined with multiple questionnaires. Implanted testosterone pellets were generally well tolerated.

CONCLUSION: Implanted testosterone pellets can normalize testosterone and LH levels and improve symptoms for at least 3 months and up to 6 months in men with hypogonadism, and should be considered as a therapeutic option for hypogonadal men.

© 2011 International Society for Sexual Medicine.

McCullough A, Khera M, Goldstein I, Hellstrom WJ, Morgentaler A, Levine LA.

CONCLUSIONS: Testosterone pellets (Testopel(®) , Slate Pharmaceuticals) provide sustained levels of testosterone for at least 4 months and up to 6 months in men with TDS. Implantation of ≥8 pellets achieved optimal results with respect to peak mean testosterone level and duration of effect. Testosterone pellets were generally well tolerated.

© 2012 International Society for Sexual Medicine.