In Brazil, testosterone is prescribed only to men with confirmed hormonal deficiency. However, the lack of clearly defined diagnostic criteria has contributed to the use of testosterone for increasing muscle mass and for other aesthetic purposes. A multidisciplinary consensus developed by the Brazilian Society of Endocrinology and Metabolism, the Brazilian Society of Urology (SBU), and the Brazilian Association for Sexual Medicine and Health (ABEMSS) seeks to address this issue.
Published in the International Brazilian Journal of Urology, the document is the first Brazilian multidisciplinary consensus on male hypogonadism. Developed by specialists in urology, endocrinology, and sexual medicine, it defines when to investigate hypogonadism, confirm the diagnosis, initiate treatment, and avoid treatment.
The Criteria
Before ordering the tests, physicians should determine whether the patient has experienced decreased libido, erectile dysfunction, or reduced spontaneous erections.
Speaking with Medscape’s Portuguese edition, Alexandre Hohl, MD, PhD, professor of endocrinology and metabolism, Department of Clinical Medicine, Federal University of Santa Catarina (UFSC), Florianópolis, Brazil, and the paper’s first author, said, “We start from the premise that we should only investigate hypogonadism in men with symptoms and signs of sexual dysfunction.”
- Investigate only men w/ ↓libido, ED, or ↓spontaneous erections.
- Nonspecific sx alone—mood change, gynecomastia, abdominal fat—don’t justify workup.
- Dx: fasting AM total T 7–10 AM; repeat ≥4 weeks later.
- T <264 ng/dL x2 confirms; >350 excludes; 264–350 needs free T.
- TRT contraindicated in prostate/breast cancer, Hct >54%, or fertility desire.
The medical history should include more than just questions about erections. “A man with decreased libido may still have erections, but his sexual desire has diminished. That is why questions about sexual function should be part of the routine medical history,” Hohl said.
Leonardo Seligra Lopes, MD, PhD, who leads the Department of Sexual Medicine and Andrology of the SBU and is vice president of the ABEMSS, added that the clinical assessment needs to be precise. “The main point is to individualize the patient and determine whether he has sexual dysfunction related to libido or other disorders related to erections.”
Nonspecific symptoms, including mood changes, gynecomastia, and abdominal fat accumulation, do not justify an investigation by themselves. “A patient may have a low testosterone level without necessarily having a deficiency. Testosterone should be measured in patients who have signs and symptoms consistent with testosterone deficiency,” Lopes said.
Laboratory diagnosis requires fasting morning total testosterone measurements between 7 AM and 10 AM. The result must be confirmed by a second test conducted at least 4 weeks later. The consensus classifies the results into three categories:
- A testosterone level < 264 ng/dL in both tests confirms the diagnosis, whereas a level > 350 ng/dL excludes it.
- For levels between 264 and 350 ng/dL, the “gray zone,” free testosterone should be calculated using the Vermeulen equation.
- A free testosterone level < 6.5 ng/dL confirms the diagnosis.
Factors that alter sex hormone-binding globulin, including obesity, diabetes, and glucocorticoid use, can affect total testosterone measurements and necessitate the calculation of free testosterone levels.
Lopes provided a clinical context for these thresholds. “A testosterone level < 330 ng/dL can already give the patient a sense of decreased libido,” he said. Erectile dysfunction tends to be associated with hypogonadism when testosterone levels are < 200 ng/dL.
Once the diagnosis is confirmed, the next step is to determine the cause of hypogonadism because the underlying cause guides the treatment. Organic hypogonadism is irreversible and can result from conditions such as Klinefelter syndrome, mumps orchitis, or structural failure of the hypothalamic-pituitary-gonadal axis. In such cases, exogenous testosterone replacement is the primary treatment.
Functional hypogonadism, in contrast, is potentially reversible and is associated with obesity, diabetes, and prolonged use of anabolic steroids and opioids. Treating the underlying cause may restore testosterone levels without replacement therapy. “The higher the BMI and the greater the abdominal adiposity, the less testosterone a person will produce,” Hohl explained. A UFSC study of 29 men with obesity who underwent bariatric surgery found increased testosterone levels 6 months after the procedure.
Treatment and Monitoring
When replacement therapy is indicated, the consensus recognizes the three formulations approved in Brazil. Short-acting injectable testosterone, administered every 2-4 weeks, produces peaks and troughs that can cause fluctuations in energy, mood, and libido. Long-acting injectable testosterone, administered every 10-14 weeks, provides more stable levels. Testosterone gel, when applied daily, mimics the circadian rhythm of hormones. Oral formulations and subcutaneous implants are not recommended because pharmacokinetic data have not yet been validated in Brazil.
Recent SCTIE/MS ordinances have officially incorporated injectable testosterone into Brazil’s Unified Health System (SUS) for men with organic hypogonadotropic hypogonadism. The SUS must officially make injectable testosterone available by mid-December 2026.
Testosterone replacement therapy is contraindicated in men with active or suspected prostate cancer, breast cancer, or a hematocrit level > 54%. For men who wish to have children, testosterone replacement is also contraindicated because exogenous testosterone suppresses the hypothalamic-pituitary-gonadal axis and may unpredictably impair sperm production. For these patients, the consensus points to alternatives, including selective estrogen receptor modulators, gonadotropins, and aromatase inhibitors. “The main message for general practitioners, geriatricians, and cardiologists is that, when choosing a formulation, they must keep fertility in mind,” Lopes said.
Monitoring is an integral part of treatment. “Testosterone can increase hematocrit; if it rises > 54%, treatment needs to be reassessed. It is important to monitor the patient and order hematocrit tests regularly,” Hohl said. Follow-up visits were scheduled every 3 months initially, then every 6 months for a total of 2 years, followed by annual visits. Prostate-specific antigen testing and digital rectal examination should be performed at 3 and 12 months in men older than 45 years.
In Practice
The consensus provides guidance but does not cover every clinical situation. Murilo Garrote, MD, urologist at Primavera Hospital in Aracaju, Brazil, described a case that illustrates this limitation. “I’ve been treating a patient who had a level of 800 ng/dL 2 years ago, and now, when we repeated the test, it had fallen to 410 ng/dL. The level is still within the normal range, but he is already beginning to show symptoms.” Garrote cautioned that waiting until a patient reaches the threshold defined in the consensus may be a mistake. “We don’t need to wait for the patient to hit rock bottom before starting treatment.”
These criteria can also be used to support the decision not to prescribe treatment when the required technical criteria are not met. “Using objective data, we can show the patient that he does not need replacement therapy. Testosterone may be one of the factors contributing to the symptoms, but it is not the only one,” Garrote concluded.
Washington Castilhos has been a science and health journalist for more than 20 years. He reported holding a master’s degree in science, health, and technology communication from the Oswaldo Cruz Foundation in Rio de Janeiro, Brazil, and a doctoral degree in education and biosciences communication from the Federal University of Rio de Janeiro, which included a doctoral internship at Paris 8 University in Saint-Denis, France.
This story was translated from Medscape’s Portuguese edition.
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