FDA release of February 2025: Current FDA TRAVERSE trials from 2023 concluded that there was no increase in the risks of adverse cardiovascular outcomes in men using TRT for hypogonadism; however, they did confirm an increase in blood pressure. This risk is more prominent with oral T undecanoate or subcutaneous T enanthate. Our skilled practitioner understands these risks, so we have developed the systems we have in place.

Additionally, T undecanoate IM carries a risk of Pulmonary oil microembolism.

Topical gels and transdermal solutions carry a risk of secondary exposure, so it is increasingly important to understand their safety.

Hepatotoxicity has been limited to oral T formulations. However, we monitor and observe this risk for all formulations.

Our standard go-to T formulation is cypionate injectable due to the additional side effects of other formulations.

So let’s talk about it.

• Blood pressure increases may be potentially secondary to fluid retention and peripheral edema. Cypionate is contraindicated in those with liver impairment due to this fluid retention. Our plan: Monitor blood pressure and peripheral edema, complete a metabolic panel, and adjust treatment as indicated.
• Polycythemia/erythrocytosis, exact mechanism unknown, hypothetical thoughts include the role of hepcidin, iron sequestration and turnover, erythropoietin production, bone marrow stimulation, and genetic factors. Our plan: monitor hematocrit and hemoglobin levels and adjust treatment as indicated, as well as therapeutic phlebotomy with HCT levels equal to or above 54%
• Prostate cancer and benign prostatic hypertrophy risks. Evidence is conflicting. With BPH, if you have a severe AUA/International Prostate Symptom Score greater than 19 and lower urinary tract symptoms, unfortunately, you are excluded from enrolling in the TRT program. If you have known prostate cancer, you will need a urology clearance before proceeding. Our plan: We monitor your PSA levels closely and refer you to urology if necessary. It is important to note that PSA levels do tend to rise directly after initiation of TRT. However, this is most often transient.
• Worsening of sleep apnea. Our plan: If you have untreated sleep apnea or suspect you have undiagnosed sleep apnea, we will refer you back to your PCP for sleep study and treatment.
• Infertility and testicular atrophy. Our plan: We recommend that if this is important to our men, they should also utilize HCG or Gonadorelin to help decrease the effects of testicular atrophy and infertility. This is a common side effect of testosterone replacement therapy. Gonadorelin may help with testicular atrophy but is inferior to HCG for fertility. HCG, due to FDA regulations, is unfortunately quite expensive. Gonadorelin, to be truly optimal, should be injected multiple times daily. However, it is rarely prescribed as such due to the high probability of noncompliance and inconvenience; therefore, providers are still prescribing gonadorelin as they would HCG. There is also the option to add HCG during times you are trying to conceive only. Every man is unique, and we are here to help you navigate your individual needs and maintain what is important to you while also balancing your hormones. HCG is utilized in our weaning protocol if you decide to discontinue TRT.
• Referenced from UpToDate

I often get men asking if their natural Testosterone Production abilities will decrease if they start on testosterone replacement therapy (TRT). It is imperative to note that TRT is considered a lifelong treatment. Once you begin and reap the benefits, you will have to continuously take the medication to keep your T levels up, as the treatment does not work only once to increase your levels and then sustain them. There is no definitive proof that your body stops producing testosterone to the point where it can’t recover after ceasing testosterone replacement therapy (TRT). Research indicates that the longer you are on TRT, the longer it may take for your body to return to “your” normal levels, and sudden drops can cause mood changes and hormone fluctuations. Our plan: If you decide to stop TRT, we will initiate a weaning protocol to help mitigate the withdrawal effects of discontinuing TRT.

It is crucial to understand these potential effects and decide what is right for you. For men with significant symptoms, TRT can be a life-changing intervention that can be utilized throughout their lives.