How are hormones monitored during therapy?

Hormone levels testing needs to be ordered and evaluated before therapy is recommended. This may include:

WOMEN

  • FSH
  • Estradiol
  • Testosterone
  • Free Testosterone

ALSO CONSIDER

  • Thyroid Hormone Levels
  • Monthly Self-Breast Exam
  • Mammogram
  • PAP

MEN

  • Prostate Specific Antigen (PSA)
  • Sensitive Estradiol
  • Testosterone Free & Total
  • Liver Function Profile
  • Lipid Profile
  • CBC
  • Estradiol
  • TSH
  • Fasting Blood Glucose (FBG)
  • HbA1C
  • Annual Rectal Exam



Levels will need to be reevaluated during hormone therapy prior to insertion of the next round of pellets, at or around 3 months. After the first year of therapy, hormones levels may be followed less frequently.


What training or certification is required to practice pellet therapy?

Training is necessity, however certification is not generally required beyond that of state mandated physician licensing. ITRI has partnered with physicians experienced in pellet implant therapy to offer all of the training and support you will need to begin administering pellet therapy.


How much time is required to administer the pellet procedure?

The pellet implant procedure takes approximately 10 minutes from initial room set up to completion. The area is prepared with a local anesthetic, the pellets are inserted with a disposable trocar, and the insertion site is closed with sterile strips. It is a fairly simple procedure that is easily scheduled in to your daily routine.


Will I need a surgical suite in my clinical or can this procedure be performed in an examination room?

The pellet implant procedure does not require a surgical suite and can be done in an examination room that is maintained using standard sterilization procedures.


Do I need to purchase special equipment to implant pellets?

The only equipment that is required for the pellet implant procedure is the trocar kit, which includes a disposable trocar all necessary supplies to administer the procedure. These are soon to be available online at SterileLabs.com.

Are there adverse reactions to pellet therapy?

The only regular adverse effect is extrusion (shown only to occur in 3 to 6% of patients), which may be related to mechanical factors such as habitual work activity but also possibly procedural factors. Other adverse effects such as bleeding (more prevalent in cases using increased number of pellets), infection (in 0.6%) and fibrosis are rare.


Can a patient be allergic to the implants?

Very rarely, a patient will develop redness and itching at the site of the implant. There is generally minimal or no tenderness and no other sign of infection. Many pellet formulations include stearic acid and PVP (Povidone). Patients may react to the PVP.

Will pellet therapy be covered under my malpractice insurance or do I need to purchase additional coverage to perform these procedures?

Every insurance policy is subject to its own limits and exclusions. It is important to review your policy to be certain of your coverage. Wellness Medical Protection Group provides specialty insurance policies for pellet implant procedures, as well as many other ancillary services. For more information visit their website, or call 855-851-2968.

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

ABSTRACT SUMMARY
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

ABSTRACT SUMMARY
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.


PHARMACOKINETIC EVALUATION AND DOSING OF SUBCUTANEOUS TESTOSTERONE PELLETS
Alexander W. Pastuszak, Harsha Mittakanti, Joceline S. Liu, Lissette Gomez, Larry I. Lipschultz, Mohit Khera, Scott Department of Urology, Baylor College of Medicine, Houston, Texas; and the Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.


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

ABSTRACT SUMMARY
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

CONCLUSION SUMMARY
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

CONCLUSION SUMMARY
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

CONCLUSION SUMMARY
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


RANDOMIZED CROSS-OVER CLINICAL TRIAL OF INJECTABLE VS. IMPLANTABLE DEPOT TESTOSTERONE FOR MAINTENANCE OF TESTOSTERONE REPLACEMENT THERAPY IN ANDROGEN DEFICIENT MEN
Carolyn Fennell, Gideon Sartorius, Lam P. Ly, Leo Turner, Peter Y. Liu, Ann J. Conway and David J. Handelsman, Andrology Department, Concord Hospital & ANZAC Research Institute, University of Sydney, Sydney, NSW, Australia Clinical Endocrinology (2010) 73, 102–109


INFLUENCE OF IMPLANTATION SITE AND TRACK GEOMETRY ON THE EXTRUSION RATE AND PHARMACOLOGY OF TESTOSTERONE IMPLANTS
S. Kelleher, A. J. Conway, D. J. Handelsman, Department of Andrology, Concord Hospital and ANZAC Research Institute, University of Sydney, Sydney, Australia Clinical Endocrinology (2001) 55, 531±536