Alex Rodriguez TRT: The Private-Clinic Pathway They Likely Used

What the Biogenesis Scandal Reveals About Private-Clinic Access

The Biogenesis case was not just a sports story. It was a window into a parallel medical economy. Anthony Bosch operated Biogenesis of America in Coral Gables, Florida, supplying testosterone, human growth hormone, and peptides to at least 20 MLB players. Rodriguez was handed a 211-game suspension (later reduced to 162 games) after MLB's investigation, one of the longest non-lifetime bans in league history.

What made Biogenesis possible was the gap between sports anti-doping rules and civil medical law. Prescribing testosterone to an adult male with documented low levels is entirely legal under the Controlled Substances Act, which classifies anabolic steroids as Schedule III substances requiring a valid prescription from a licensed practitioner. Controlled Substances Act scheduling is maintained by the DEA, and the FDA's approval of testosterone formulations for male hypogonadism is documented in multiple accessdata.fda.gov label records.

How Private Clinics Differ from Standard Endocrinology Practice

A board-certified endocrinologist at a hospital system follows the Endocrine Society's 2018 Clinical Practice Guideline, which requires two fasting morning total testosterone measurements below 300 ng/dL plus consistent clinical symptoms before initiating therapy. That guideline is published in the Journal of Clinical Endocrinology and Metabolism.

Private hormone clinics, sometimes branded as "men's health" or "anti-aging" centers, often operate with looser internal thresholds. Some order a single testosterone draw without a fasting requirement. Others treat men with levels in the 350 to 450 ng/dL range if symptoms are present, a practice the Endocrine Society does not endorse for routine clinical care but that is not explicitly illegal.

The Role of Telemedicine and Compounding Pharmacies

After 2020, the telehealth expansion accelerated this model dramatically. A man could complete an online intake, have blood drawn at a local Quest or LabCorp, and receive a testosterone prescription shipped from a compounding pharmacy within days. Compounded testosterone cypionate in sesame or cottonseed oil remains widely available. The FDA has noted concerns about compounded hormone preparations, specifically around sterility and dosing consistency, in its guidance on compounding under 503A and 503B.

What Testosterone Replacement Therapy Actually Involves

TRT is an FDA-approved treatment for male hypogonadism, defined as a clinical syndrome combining low serum testosterone and specific symptoms such as reduced libido, fatigue, loss of muscle mass, and depressed mood. The FDA label for testosterone cypionate injection lists hypogonadism due to primary or secondary causes as the approved indication.

Diagnosis: The Lab Work That Has to Come First

The Endocrine Society's 2018 guideline specifies total testosterone measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the gold-standard assay. Two separate morning measurements (typically 7 to 10 a.m., fasting) below 300 ng/dL establish biochemical hypogonadism. The published guideline states: "We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone deficiency and unequivocally low serum testosterone concentrations."

Free testosterone becomes relevant when sex hormone-binding globulin (SHBG) is abnormally high or low, which can occur in obesity, liver disease, or thyroid disorders. A man with a total testosterone of 320 ng/dL but severely elevated SHBG may have biologically significant free testosterone deficiency.

Standard Protocol: Doses, Formulations, and Frequency

The most commonly prescribed formulation in the United States remains testosterone cypionate, a long-acting ester administered intramuscularly or subcutaneously. A typical starting dose is 100 mg IM weekly or 200 mg IM every two weeks, with weekly dosing preferred by most clinicians because it produces more stable serum levels.

Transdermal options include 1.62% testosterone gel (AndroGel), which the FDA approved in 2011. In clinical trials supporting that approval, 182 patients using 1.62% gel achieved mean total testosterone levels of 489 ng/dL at week 16. FDA review documents for AndroGel 1.62% detail the pharmacokinetic data.

Testosterone undecanoate (Aveed, Jatenzo) is a longer-acting option. Aveed is administered as a 750 mg IM injection at initiation, again at 4 weeks, then every 10 weeks thereafter. The Aveed prescribing information carries a boxed warning for pulmonary oil microembolism, requiring a 30-minute observation period post-injection.

What Athletes Like Rodriguez Likely Received vs. Therapeutic Doses

Here is where the clinical picture diverges sharply from the performance picture. A therapeutic dose of testosterone cypionate raises serum testosterone to the mid-normal range, roughly 400 to 700 ng/dL. That is the goal for a hypogonadal man. Athletic doping protocols, by contrast, may involve doses of 300 to 600 mg per week or higher, producing supraphysiologic levels that dramatically exceed the upper reference range of roughly 1,000 ng/dL. At those doses, testosterone acts pharmacologically as an anabolic agent, not as hormone replacement.

A 2004 trial by Bhasin et al. Published in the New England Journal of Medicine demonstrated the dose-response relationship clearly: graded doses of testosterone enanthate from 25 mg to 600 mg per week produced progressively greater increases in fat-free mass and strength, with the largest gains at 300 and 600 mg/week. That landmark study is available at NEJM. The 600 mg/week group gained an average of 7.9 kg of fat-free mass over 20 weeks without any exercise. Those numbers have nothing to do with treating hypogonadism.

The Private-Clinic Pathway: Step by Step

Understanding how a private clinic funnels a patient from intake to injection helps explain why the Biogenesis model worked and why similar clinics continue to operate legally.

Step 1: Intake and Symptom Screening

Most private men's health clinics use a validated questionnaire. The Aging Males' Symptoms (AMS) scale and the ADAM (Androgen Deficiency in the Aging Male) questionnaire are both commonly deployed. ADAM was validated in a study of 316 men aged 40 to 62 and showed a sensitivity of 88% for detecting testosterone deficiency, though its specificity is only 60%, meaning false positives are common. That validation study is indexed on PubMed.

A clinic optimized for conversion rather than careful diagnosis may weight the symptom questionnaire heavily and order labs only to satisfy a documentation requirement.

Step 2: Laboratory Panel

A minimally adequate panel before TRT initiation includes: total testosterone (two morning draws), free testosterone or calculated free testosterone, LH and FSH (to distinguish primary from secondary hypogonadism), hematocrit, PSA, comprehensive metabolic panel, and lipid panel. The Endocrine Society guideline also recommends prolactin if secondary hypogonadism is suspected.

Clinics that order only a single total testosterone draw, or that skip LH/FSH, cannot properly classify the cause of low testosterone. A man with secondary hypogonadism due to a pituitary adenoma needs imaging and specialist referral, not a testosterone prescription. PubMed indexed a 2019 review of pituitary causes of male hypogonadism that underscores why the full panel matters.

Step 3: Prescription and Formulation Choice

Once labs meet the clinic's threshold, a prescribing physician or, in some states, a nurse practitioner or physician assistant issues the prescription. Testosterone is Schedule III, so a valid patient-prescriber relationship and a legitimate diagnosis must exist. In practice, the DEA has prosecuted cases where prescribers issued testosterone without adequate examination.

Compounding pharmacies frequently supply private clinics with testosterone cypionate in concentrations not available commercially (e.g., 200 mg/mL in 10 mL multidose vials), along with ancillary compounds such as anastrozole (an aromatase inhibitor to control estradiol conversion) and human chorionic gonadotropin (hCG, used to preserve testicular function and fertility on TRT).

Step 4: Monitoring

The Endocrine Society recommends measuring testosterone levels 3 to 6 months after initiation, with the goal of achieving mid-normal range levels. Hematocrit must be monitored because testosterone stimulates erythropoiesis. A hematocrit above 54% is a standard threshold for dose reduction or temporary discontinuation, given the increased risk of thrombotic events. A 2013 meta-analysis in JAMA found that testosterone therapy was associated with increased cardiovascular events in older men with high cardiovascular risk, a finding that generated significant guideline discussion.

PSA should be checked at 3 months and then annually in men over 40 to screen for prostate cancer stimulation, per FDA prescribing label guidance.

The Science Behind TRT Benefits and Risks

What Controlled Trials Show

The Testosterone Trials (TTrials), a coordinated set of seven placebo-controlled trials involving 790 hypogonadal men aged 65 or older, provide the most rigorous data on TRT outcomes in older men. Published in the New England Journal of Medicine in 2016, the sexual function trial showed that testosterone treatment produced significantly greater improvements in sexual desire and erectile function compared with placebo. The primary TTrials publication is at NEJM.

The physical function trial within TTrials found that testosterone improved walking distance modestly but did not significantly improve physical function scores compared with placebo, a more sobering finding for the performance enhancement narrative.

Cardiovascular Risk: An Ongoing Debate

The FDA added a warning to all testosterone products in 2015 regarding a possible increased risk of myocardial infarction and stroke, based on pharmacoepidemiologic data. That FDA Drug Safety Communication is available on fda.gov.

The TRAVERSE trial, the first large randomized cardiovascular outcomes trial of testosterone, enrolled 5,204 men aged 45 to 80 with hypogonadism and pre-existing or high risk of cardiovascular disease. Results published in 2023 in the New England Journal of Medicine found that testosterone replacement did not increase major adverse cardiovascular events (MACE) compared with placebo (hazard ratio 0.96, 95% CI 0.78 to 1.17). The TRAVERSE trial publication is available at NEJM. However, testosterone was associated with higher rates of atrial fibrillation, acute kidney injury, and pulmonary embolism.

Fertility and Testicular Suppression

Exogenous testosterone suppresses the hypothalamic-pituitary-gonadal axis, reducing LH and FSH and causing testicular atrophy and azoospermia within months. A 1996 WHO contraception trial using testosterone enanthate 200 mg weekly achieved azoospermia or severe oligospermia in 98% of men within 12 months. That trial is indexed at PubMed. Recovery of spermatogenesis after discontinuation can take 6 to 18 months and may be incomplete in some men. This is why clinics prescribing hCG alongside TRT are attempting to preserve the HPG axis signal.

Peptides and Ancillary Compounds: The Full Stack

Biogenesis reportedly supplied not only testosterone but also growth hormone secretagogues and peptides. Understanding what these compounds are helps contextualize the clinical pathway.

Human Growth Hormone and Secretagogues

Recombinant human growth hormone (somatropin) is FDA-approved for adult GHD (growth hormone deficiency) and several other specific conditions. It is not approved for anti-aging or athletic performance. Off-label use in healthy adults is not supported by strong efficacy data for muscle mass in the absence of true GHD. A Cochrane review of GH in adults with GHD found modest improvements in body composition but no evidence of functional benefit.

Peptide secretagogues such as sermorelin (a GHRH analogue) and ipamorelin stimulate endogenous GH release rather than providing exogenous GH. Sermorelin is FDA-approved for pediatric growth hormone deficiency. Its use in adults for anti-aging or body composition is off-label. Sermorelin's original FDA approval is documented in the accessdata.fda.gov database.

Anastrozole Use in TRT Protocols

Many private clinics co-prescribe anastrozole (an aromatase inhibitor) to manage estradiol levels that rise as testosterone is aromatized. The FDA-approved indications for anastrozole are breast cancer in postmenopausal women. Its use in men on TRT is entirely off-label.

Estradiol in men has documented physiologic roles: bone mineral density maintenance, libido, and cardiovascular health. Suppressing it aggressively may cause harm. A study by Finkelstein et al. In the New England Journal of Medicine showed that estradiol deficiency, produced by aromatase inhibition, was the primary driver of fat accumulation and bone loss in men, independent of testosterone levels. That study is available at NEJM. Routine anastrozole co-prescription in men with normal estradiol is not supported by current evidence.

Legitimate TRT vs. Athletic Doping: The Clinical Line

The distinction between medically supervised TRT and performance-enhancing doping is dose and intent. A man with total testosterone of 210 ng/dL, confirmed fatigue, reduced bone density, and loss of lean mass is a legitimate candidate for TRT. Bringing his levels to 550 ng/dL with 100 mg testosterone cypionate weekly is treatment. Administering 500 mg weekly to a man with a baseline of 600 ng/dL to achieve supraphysiologic levels of 2,000+ ng/dL is doping, regardless of whether a prescription exists.

MLB's joint drug agreement bans testosterone at any dose above a urine testosterone-to-epitestosterone (T/E) ratio of 4:1. WADA uses the same 4:1 ratio as its threshold for isotope-ratio mass spectrometry confirmation. The science behind that threshold draws on naturally occurring T/E distributions in healthy men, which are described in detail in WADA's Technical Document TD2021EAAS. WADA's anti-doping science resources are available at wada-ama.org.

A private clinic prescribing supraphysiologic testosterone while documenting a hypogonadism diagnosis is operating in a legal grey area. The physician may be technically in compliance with state licensing law while knowingly enabling a doping protocol. That is precisely the model federal investigators found at Biogenesis.

Who Is Actually a Candidate for TRT?

Not every man who feels tired or has reduced libido has hypogonadism. The prevalence of biochemically confirmed hypogonadism (total testosterone <300 ng/dL on two separate draws) in adult men is approximately 2 to 6%, rising with age. A Massachusetts Male Aging Study cohort found that the prevalence of symptomatic androgen deficiency was 6.0% in men aged 40 to 69. That epidemiologic study is indexed at PubMed.

The Endocrine Society guideline explicitly recommends against TRT in men who are trying to conceive, in men with hematocrit above 54%, in men with untreated obstructive sleep apnea, in men with uncontrolled heart failure, and in men with a history of prostate or breast cancer.

Lifestyle optimization should precede TRT consideration. Weight loss in obese men raises testosterone. A study of 900 men showed that a 10% reduction in body weight corresponded to an approximately 40 to 50 ng/dL increase in total testosterone. That finding is supported by data indexed at PubMed.