Adherence to Male Hypogonadism Treatment Guidelines Is Low
Off-label use of testosterone replacement therapy (TRT) has risen in recent years, corresponding with the advent of direct-to-consumer (DTC) advertising for TRT and the emergence of 'low T' clinics, Petra Pederson, MD, PhD, chief resident in internal medicine at Scripps Clinic/Green Hospital, San Diego, said at the ENDO 2025: The Endocrine Society Annual Meeting.
'This led to our hypothesis that [DTC] advertising in the presence of online clinics creates patient expectations that make it challenging for clinicians to practice evidence- and guideline-based care,' she said.
Pederson and colleagues conducted a two-part study of adherence to TRT prescribing guidelines at their institution. The first part involved a retrospective chart review of 269 men who were prescribed TRT from January 1, 2019, through June 30, 2023, examining adherence to the 2018 Endocrine Society clinical practice guideline (CPG).
Of the 269 TRT prescriptions, 67.3% were from primary care providers (54% internal medicine and 13% family medicine) and 32.7% from specialists (25% urology and 8% endocrinology). The majority of patients (72.1%) stayed on treatment for at least 1 year, with an average treatment duration of 25 months.
Criteria for adherence was defined as:
Confirmation of the diagnosis of hypogonadism with two separate low (< 264 ng/dL) early morning total testosterone levels. Determination of the etiology of hypogonadism by measuring luteinizing hormone (LH) and follicle-stimulating hormone (FSH) with appropriate laboratory or imaging follow-up based on the results. On-treatment therapeutic monitoring with total testosterone levels drawn at 3-6 months and 12 months. On-treatment safety monitoring, with hematocrit at baseline and at 3-6 months, with dose reduction if necessary and discontinuation if > 54%.
Overall, the proportion of clinicians, primary care, and specialists combined who followed all four criteria was just 5.9%. The difference between primary care (3.3%) and specialists (11.4%) was statistically significant ( P = .009).
By individual criteria, 17.8% overall had no low testosterone level prior to treatment, 21% among the primary care group vs 10.2% for the specialists. This difference was also significant ( P = .023).
Follow-up total testosterone measurement at 3-6 months was performed for only 50% overall, 44.1% by primary care, and 62.5% by the specialists. Hematocrit testing at 3-6 months was measured at 54% overall, 48.0% by the primary care, and 65.3% by specialists. Both specialty differences were again significant ( P = .01 and P = .06, respectively).
Between the two specialties, endocrinologists were more likely than urologists to follow all four criteria, 23.8% vs 7.5%, respectively ( P = .054), and were much more likely to have LH and FSH drawn (85.7% vs 16.4% for LH; P < .001).
'We postulate that these striking differences between endocrinology and urology could be related to the fact that urologists were seeing more patients who present with sexual dysfunction compared to endocrinologists, and perhaps they have more pressure to prescribe,' Pederson said.
Barriers: DTC Advertising, Misinformation, Test Inaccuracy
The second part of the study involved a survey to which 51 Scripps providers responded. Of those, 74% were primary care (41% internal medicine and 33% family medicine), 18% endocrinologists, and 8% urologists. All 51 reported having seen one or more patients in the last 6 months who requested TRT.
The specialists were significantly more likely to report being comfortable with the guidelines than were the primary care providers and to prescribe TRT more often. A total of 74.5% overall felt that DTC advertising and testosterone 'clinics' were significant public health issues. A similar majority (76.5%) felt there was a need for more educational tools.
Barriers to providing guideline-based care identified by the providers included misinformation through advertising or social media, for-profit 'low T' clinics that contradict evidence-based guidelines, patient dissatisfaction when guidelines don't align with their expectations, vague and subjective symptoms, and test inaccuracy and variability. 'We're planning to address this at our institution with a quality improvement initiative,' Pederson said.
She acknowledged that the American Urological Association guidelines use a low testosterone cutoff of < 300 ng/dL, 'so we might underestimate guideline adherence with our criteria.' And she noted that a small number of primary care providers accounted for a disproportionate number of the prescriptions in their sample, which could limit generalizability.
In response to a question from the audience about why the guideline adherence was so low even among specialists, Pederson responded, 'I think that they're experiencing some of the same challenges that PCPs are experiencing, which is the pressure from their patients, and also maybe issues related to tests and accuracy. And I just think the difficulty of getting patients to do all these follow-up tests when they're looking for a simple fix.'
Improvements Are Underway, Patient Education Is Key
Asked to comment, the Endocrine Society's CPG lead author Shalender Bhasin, MB, professor of medicine at Harvard Medical School and director of the Research Program in Men's Health: Aging and Metabolism at Brigham and Women's Hospital, Boston, told Medscape Medical News that these findings align with those of a study his group conducted a decade ago in the Veterans Administration (VA), but that the VA has since implemented system-wide improvements. 'I think it's gotten much better. In the VA, it was very low, and it has gotten substantially better because at the VA now there's one policy. Also, the assays have gotten better.'
Bhasin also pointed out that the prescribing of testosterone has fluctuated over time, dropping in 2013 after an FDA advisory about cardiovascular risk but then rising again around 2017 following the TRAVERSE trial results showing cardiovascular safety.
The subsequent rise has been slower, but, Bhasin noted, 'testosterone sales are growing, and at the same time, many men with testosterone deficiency remain undiagnosed, so it's both overuse and underuse.'
Also asked to comment, session moderator Ismat Shafiq, MD, of the University of Rochester, Rochester, New York, told Medscape Medical News that patients will commonly have low total testosterone due to overweight or obesity and/or sleep apnea but will have normal free testosterone. 'If that's the case, we can properly educate our patients and work on managing their weight and sleep problems. That can reverse the hypogonadism and make them feel better, rather than giving them testosterone.'
And if they have both low total and free testosterone, the cause could be something reversible, such as a prolactinoma or pituitary macroadenoma. 'If we check the prolactin level and we treat them, the hypogonadism will resolve. Primary hypothyroidism, too, if treated, can resolve the hypogonadism,' Shafiq said. 'Diagnosing the patient appropriately can identify causes that can be treatable and that can improve their quality of life and improve their testosterone level too, rather than jumping into giving them testosterone.'
She also noted that many patients mistakenly believe that more testosterone is better. 'We need to educate them. In my experience, most of the patients listen and understand because nobody wants to take extra medicine all the time, unless it's really needed for them to improve their quality of life.'
Pederson and Shafiq reported having no disclosures. Bhasin reported receiving research grant support from AbbVie and Metro International Biotech for investigator-initiated research, with the grants managed by Brigham and Women's Hospital. He has served as a consultant to Besins and Versanis and has an equity interest in XYone Therapeutics.
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