Testosterone Replacement Therapy (TRT) for Men With Diagnosed Hypogonadism

About the Method

About the Virden Method™

The Virden Method™ is an in-office testosterone hormone replacement therapy technique developed by Charles P. Virden, MD, and licensed to Amavita Heart and Vascular through VitalTE Lifesciences Inc. Under our license, Amavita is authorized to use the Virden Method™ at our clinics in the State of Florida. Only Amavita clinicians who have completed the Virden training curriculum perform the procedure at our practice. The Virden Method™ is a trademark of Charles P. Virden, MD, and is licensed to Amavita through VitalTE Lifesciences Inc.; more information about the Method is available at therapellet.com/the-virden-method.

Who Is a Candidate for TRT?

We follow the Endocrine Society's 2018 Clinical Practice Guideline, which recommends "diagnosing hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations" (Bhasin et al., J Clin Endocrinol Metab 2018;103(5):1715–1744; DOI 10.1210/jc.2018-00229; PMID 29562364).

To be considered for TRT at Amavita, a patient must have all of the following:

• Two separate early-morning, fasting total testosterone measurements, on different days, both below the laboratory reference range — the American Urological Association identifies "a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone" (Mulhall et al., J Urol 2018;200(2):423–432; DOI 10.1016/j.juro.2018.03.115; PMID 29601923);
• Documented signs and symptoms consistent with testosterone deficiency (e.g., reduced libido, erectile dysfunction, loss of body hair, low bone density);
• An in-person evaluation by one of our physicians, including history, physical examination, and review of contraindications; and
• Written informed consent after a risk-benefit discussion.

We do not prescribe testosterone for:

• Age-related decline in testosterone without confirmed hypogonadism. The FDA has approved testosterone "only for men who have low testosterone levels caused by certain medical conditions," and cautions that the "benefit and safety of these medications have not been established" for low testosterone due to aging (FDA Drug Safety Communication, March 3, 2015);
• Athletic or physique enhancement;
• General wellness, "energy," or "vitality" in men with normal testosterone levels.

Who Should NOT Receive TRT (Contraindications)

Per the Endocrine Society 2018 guideline, we do not start testosterone therapy in men with any of the following:

• Prostate cancer (active or suspected), a palpable prostate nodule or induration, PSA > 4 ng/mL (or > 3 ng/mL with elevated prostate cancer risk) without urologic evaluation
• Breast cancer
• Elevated hematocrit (erythrocytosis); therapy is stopped if hematocrit exceeds 54%
• Severe untreated obstructive sleep apnea
• Uncontrolled or poorly controlled heart failure
• Severe lower urinary tract symptoms (IPSS > 19)
• Myocardial infarction or stroke within the past 6 months
• Desire for fertility in the near term (testosterone suppresses sperm production)
• Thrombophilia (a clotting disorder)

Source: Bhasin et al., Endocrine Society Clinical Practice Guideline, 2018 (PMID 29562364).

What Benefits Does the Evidence Actually Support?

In men with confirmed hypogonadism, randomized-trial evidence (including the Testosterone Trials, Snyder et al., N Engl J Med 2016;374:611–624; DOI 10.1056/NEJMoa1506119; PMID 26886521) supports:

• Sexual function: modest, consistent improvements in libido and sexual activity;
• Mood: small improvements in mood and depressive symptoms;
• Body composition: increased lean body mass and decreased fat mass (effects on strength and physical function are modest);
• Anemia and bone density: improvement in unexplained anemia and in volumetric bone mineral density in older hypogonadal men.

What the evidence does not clearly support: the Testosterone Trials' Vitality Trial did not show a significant improvement in fatigue/energy versus placebo, and testosterone did not improve cognitive function. We do not promise specific results, and individual responses vary. Any percentage "success rates" you see advertised elsewhere without a cited study, denominator, and confidence interval should be treated with skepticism.

Is Testosterone Therapy Safe for My Heart?

What did the TRAVERSE trial show?

TRAVERSE (Lincoff et al., N Engl J Med 2023;389:107–117; DOI 10.1056/NEJMoa2303053; PMID 37326322) enrolled 5,246 men aged 45–80 with hypogonadism and elevated cardiovascular risk. It was a non-inferiority trial: testosterone gel was found non-inferior to placebo for major adverse cardiac events (hazard ratio 0.96; 95% CI 0.78–1.17). TRAVERSE did not show that testosterone reduces or protects against cardiovascular events, and it does not apply to men without diagnosed hypogonadism.

Did TRAVERSE identify any risks?

Yes. The testosterone group had higher rates of atrial fibrillation, acute kidney injury, and pulmonary embolism than placebo. We screen for and discuss these risks before treatment.

What does the FDA say?

FDA-approved testosterone labeling carries class-wide warnings that some studies have reported a possible increased risk of heart attack and stroke with testosterone use (FDA Drug Safety Communication, March 3, 2015), and a class-wide warning regarding abuse and dependence (FDA, October 25, 2016). Testosterone is a Schedule III controlled substance under federal law. As a cardiology-led practice, we take these warnings seriously and will review them with you in person before any prescription.

Risks and Side Effects

Testosterone therapy can cause or worsen:

• Erythrocytosis (elevated red blood cell count, the most common laboratory adverse effect), which can increase clotting risk
• Prostate effects, including PSA elevation and stimulation of existing prostate tissue; effects on prostate cancer risk require ongoing monitoring
• Suppression of sperm production and fertility (may be prolonged or, rarely, irreversible)
• Acne and oily skin; breast tenderness or enlargement (gynecomastia)
• Worsening of obstructive sleep apnea
• Fluid retention (edema)
• Possible increased cardiovascular risk, per FDA class labeling described above

Pellet-specific risks: pellet insertion is a minor surgical procedure performed under local anesthesia. Risks include bleeding, bruising, insertion-site infection, pain, and pellet extrusion (the pellet working its way out of the skin), which may require re-insertion. Pellet dosing is less adjustable than gels or injections; once inserted, pellets cannot easily be removed if side effects occur.

About the Pellets We Use

Amavita uses compounded testosterone pellets prepared by a licensed compounding pharmacy under Section 503A of the Federal Food, Drug, and Cosmetic Act. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety, effectiveness, or quality. Compounded pellets are prescribed on a patient-specific basis when an FDA-approved product is not clinically appropriate for the individual patient. We will discuss the compounded nature of your medication as part of the informed-consent process before treatment.

Laboratory Monitoring: What We Require

Source: Endocrine Society 2018 guideline (PMID 29562364).

Therapy is held or discontinued if hematocrit exceeds 54%, if PSA findings require urologic evaluation, or if significant adverse effects develop. Patients who do not attend monitoring visits cannot safely continue therapy.

Informed Consent Is Required

TRT at Amavita requires written informed consent before the first prescription or pellet insertion. Your consent discussion and form will cover, at minimum:

• The FDA class warnings described above, including possible cardiovascular risk and abuse potential, which you will be asked to acknowledge in writing;
• That the pellets we use are compounded and not FDA-approved;
• That pellet insertion is a surgical procedure with infection and extrusion risk;
• Effects on fertility and alternatives if you may want children;
• Alternatives to pellets (gels, injections, patches) and the option of no treatment;
• Your right to decline or discontinue therapy at any time.

Our Cardiology Services Are Separate From This Program

Amavita is a cardiology practice, and some TRT candidates independently need cardiovascular evaluation. To protect your right to make independent medical decisions:

• Testosterone therapy at Amavita is not sold as a package or "program" that includes cardiac testing, coronary calcium scoring, imaging, or supplements.
• Cardiovascular tests are ordered only when independently medically indicated, documented separately, consented to separately, and billed separately. Being on testosterone therapy is not, by itself, a medical indication for a calcium score or other cardiac imaging.
• You are free to obtain any cardiovascular testing or care from any provider you choose. Receiving TRT here creates no obligation to use Amavita's cardiology services, and declining cardiac testing will not affect your access to TRT unless your physician determines it is medically necessary for safe treatment.

Pricing

We charge on a fee-for-service basis: an office evaluation, laboratory testing (which may be billable to your insurance), and a per-procedure pellet insertion fee with included insertion-site follow-up. We do not sell subscription "tiers" or bundle unrelated services. Contact our office for current fees, which we will provide in writing before treatment. If a service is not covered by your insurance, you will be told the cost in advance.