YOU MAY NOT BE A CANDIDATE FOR TESTOSTERONE PELLETS OR INJECTION THERAPY IF:

• You currently have, or were diagnosed with, cancer within the past 24 months.
• You have had a serious cardiovascular event (stroke, heart attack, pulmonary embolism, or cardiothoracic surgery) within the past 24 months.
• You have epilepsy or an uncontrolled seizure disorder (seizure within the past 12 months).
• Your PSA test result is 2.5 or greater (you will require a urology evaluation and clearance before testosterone pellet treatment can be approved by our providers).

INSTRUCTIONS FOR PRE-TREATMENT (EVALUATION) LAB WORK
Fasting for 8 hours prior to your blood draw is required. Please do not take any medication before the blood draw. Additionally, make sure to drink plenty of water beforehand.

INITIAL EVALUATION
Comprehensive Lab Work & Hormone Consultation. This evaluation is conducted to assess your overall health and determine whether bio-identical testosterone replacement therapy is a viable treatment option for you.

$289 --- Comprehensive Lab Work & 4-week Follow-up Labs:

$ 350 --- Initial Consultation with Our BHRT Provider (via telemedicine/phone or in-office):
This is typically a 60-minute appointment to discuss your lab results, symptoms, and medical history to determine whether you are a candidate for bio-identical testosterone pellets or injection therapy.

 

TREATMENT COSTS
TESTOSTERONE PELLETS TREATMENTS:
$800 — Bio-identical Testosterone Pellets Treatment: Includes 6 months of testosterone pellet treatment.

• Office visit with a BHRT provider to discuss your individualized treatment plan immediately prior to the insertion of your pellets.
• Insertion of hormone pellets (up to a maximum dose of 2400 mg of testosterone pellets).
• $350 off if choose the first pellets insertion during the initial consultation.

TESTOSTERONE INJECTIONS:
6-month Testosterone Weekly Injections: Includes 6 months of injections (Monthly refills) and all necessary supplies. (Additional mailing fee applies for mail delivery).

Various Costs for Pharmacy Prescriptions (6-month supply) Sent to Pharmacy:
Costs may vary depending on your pharmacy, GoodRx coupon, or insurance coverage. Please check with your pharmacy for the most accurate pricing options.

STEPS FOR INITIAL EVALUATION:
Register your account on our website. (Check your email for 3 items)

1. Male New Patient Packet (Please complete it before your initial consultation).
   
2. BHRH Male Instructions and Consent
   
3. Pre-evaluation lab work ($289) and instructions to schedule your blood draw at any Labcorp or Quest near you.

Instructions to schedule your initial consultation (7-10 days after your blood draw) with our BHRT provider on our website to review your lab results and medical history. This appointment can be either a telemedicine or office visit, whichever you prefer.

HOW TO MAINTAIN PELLET THERAPY:

• Pellet replacement: Usually repeated every 5-6 months.
  
• Scheduling: Schedule your next pellet treatment either in-office or online.

Bio-identical testosterone is biologically identical to the testosterone hormone you make in your own body. Testosterone is derived from the testicles (primarily) and adrenal glands (secondarily) prior to andropause.

Testosterone supplementation, in medical research, has been shown to improve fatigue, exercise intolerance, muscle tone, libido, weight, and other conditions. It has been shown in research studies to decrease the risk of cardiovascular disease, diabetes, metabolic syndrome, and prostate cancer.

Though laboratory assays can support a diagnosis of testosterone deficiency, they should not be used to exclude it as there are multiple problems in the measurement of testosterone (ex. dietary intake, sexual activity, sample storage variables, circadian variations). Greater reliance on the clinical features and consideration of symptoms is suggested as an appropriate tool in treating men with testosterone therapy. The generally accepted cutoff for low "normal" serum total testosterone is 300 ng/dl. It is reasonable to prescribe testosterone to a man who has symptoms of low testosterone and to expect testosterone values that are supraphysiologic after treatment.

All testosterone use in men with a serum level of more than 300 ng/dl is considered "off label use." Off-label use refers to the use of any medication for something other than its FDA (Food and Drug Administration) approval. Many medications prescribed in the US are prescribed for off-label use. The off-label use of testosterone therapy has not been evaluated by the FDA and any claims of benefit are purely educated opinions that come from consideration of various medical research studies.

Hormone pellet production is highly FDA regulated; however, the testosterone pellet insertion procedure is not an FDA approved procedure for hormone replacement in the pellet doses we use for men (200 mg pellet).

Goals for treatment will be discussed at each appointment. If goals are met, then maintenance doses will be discussed. If the treatment is not as effective as anticipated, it might be discontinued; at that time, alternative therapies will be discussed. You are welcome to seek a second opinion or a specialist consultation.

SIDE EFFECTS: Side effects of testosterone will be managed clinically and individually. There have been no reported irreversible side effects of testosterone noted in the literature to date.

Potential side effects of testosterone therapy may include, but are not limited to:

Hyper-sexuality (overactive libido), increased hemoglobin and hematocrit (erythrocytosis), acne, increase in body/facial hair growth, hair loss/thinning and virilization, testicular shrinkage, and reduction of sperm production that may take up to a year or more to normalize to baseline.

Potential side effects of pellet insertion may include, but not limited to: Bleeding, bruising, swelling, and pain; extrusion of pellets; infection or abscess formation; seroma formation; scarring at insertion site; keloid scar. Surgical risks are the same as for any minor medical procedure.

Potential side effects of intramuscular injection may include, but not limited to: Pain or redness at the injection site.

Evidence linking testosterone therapy to the development of prostate cancer has not been established. In fact, a meta analysis of 197 studies demonstrated that testosterone administration does not increase the risk of prostate cancer. High testosterone does not predispose a man to prostate cancer and low testosterone is not protective. There is some risk, even with natural testosterone therapy, of stimulating an existing prostate cancer to grow more rapidly. Following the American Urological Association recommendations for the evaluation and management of testosterone deficiency, a prostate specific antigen blood test is to be done before starting testosterone pellet therapy in men over 40 and annual labs may be required at the discretion of your healthcare provider. If there is concern about possible prostate cancer, additional testing and/or follow up with specialist may be required.

CONSENT FOR TREATMENT: I have been informed that I may experience any of the complications related to testosterone replacement and if choosing pellet therapy, complications of the pellet placement procedure. Periodic adjustments are required to fine tune the treatment with this type of medication. Periodic blood tests are necessary to determine if the dose needs to be adjusted. I understand that testosterone supplementation is available in several forms including cream, oral formulation, injections, and subcutaneous pellets. I understand that I am consenting to testosterone therapy for off label use of my symptoms if my baseline serum testosterone levels are over 300ng/dl. I understand the hormone pellet procedure is not FDA approved.

AFTERCARE: I agree to immediately report to my practitioner’s office any adverse reaction or problems that might be related to my therapy. Potential complications have been explained to me and I agree that I have received information regarding those risks, potential complications and benefits, and the nature of hormone and other treatments and have had all my questions answered. Furthermore, I have not been promised or guaranteed any specific benefits from the administration of hormone therapy. I accept these risks and benefits, and I consent to the treatment with testosterone in the agreed upon delivery mechanism with a dosage regime discussed thoroughly by my hormone provider.

I have read and understand this document in its entirety and have been given the opportunity to ask questions concerning my care. I consent to testosterone therapy and if pellets are desired, to the subcutaneous hormone pellet insertion. This consent is ongoing for this and all future testosterone replacement of all delivery mechanisms.

References:
Gururani, K., Jose, J., & George, P. V. (2016). Testosterone as a marker of coronary artery disease severity in middle aged males. Indian heart journal, 68, S16-S20.

Lucas-Herald, A. K., Alves-Lopes, R., Montezano, A. C., Ahmed, S. F., & Touyz, R. M. (2017). Genomic and non-genomic effects of androgens in the cardiovascular system: clinical implications. Clinical Science, 131(13), 1405-1418.

Chistiakov, D. A., Myasoedova, V. A., Melnichenko, A. A., Grechko, A. V., & Orekhov, A. N. (2018). Role of androgens in cardiovascular pathology. Vascular health and risk management, 14, 283.

Kay-Tee, K., & Chir, M. B. B. (2007). Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men. Am Heart Association, 116, 2694-701.

Malkin, C. J., Pugh, P. J., Morris, P. D., Kerry, K. E., Jones, R. D., Jones, T. H., & Channer, K. S. (2004). Testosterone replacement in hypogonadal men with angina improves ischemic threshold and quality of life. Heart, 90(8), 871-876.

Jones, T. Hugh, and Daniel M. Kelly. "Randomized controlled trials–mechanistic studies of testosterone and the cardiovascular system." Asian journal of andrology 20.2 (2018): 120

Goodale, Travis, et al. "Testosterone and the Heart." Methodist DeBakey cardiovascular journal 13.2 (2017): 68

Ohlander, S. J., Varghese, B., & Pastuszak, A. W. (2018). Erythrocytosis following testosterone therapy. Sexual medicine reviews, 6(1), 77-85.

Mithoowani, S., Laureano, M., Crowther, M. A., & Hillis, C. M. (2020). Investigation and management of erythrocytosis. CMAJ, 192(32), E913-E918.

Gordeuk, V. R., Key, N. S., & Prchal, J. T. (2019). Re-evaluation of hematocrit as a determinant of thrombotic risk in erythrocytosis. haematologica, 104(4), 653-658.

Carruthers M, Trinick TR, Wheeler MJ. The validity of androgen assays. The Aging Male. 2007; 10:165-172.

Carruthers, M. (2008). The paradox dividing testosterone deficiency symptoms and androgen assays: a closer look at the cellular and molecular mechanisms of androgen action. The journal of sexual medicine, 5(4), 998-1012.

Morgentaler, A. (2012). Goodbye androgen hypothesis, hello saturation model. European urology, 62(5), 765-767. 2005

Morgentaler, A., Lipshultz, L. I., Bennett, R., Sweeney, M., Avila, D., & Khera, M. (2011). Testosterone therapy in men with untreated prostate cancer. The Journal of urology, 185(4), 1256-1261.

Morgentaler, A., Zitzmann, M., Traish, A. M., Fox, A. W., Jones, T. H., Maggi, M., ... & Torres, L. O. (2016, July). Fundamental concepts regarding testosterone deficiency and treatment: international expert consensus resolutions. In Mayo Clinic Proceedings (Vol. 91, No. 7, pp. 881-896).