Low Adherence to Male Hypogonadism Treatment Guidelines Raises Concerns

In a recent study presented at the Endocrine Society's annual meeting, ENDO 2025, researchers uncovered troubling trends regarding the adherence to treatment guidelines for male hypogonadism, revealing that only 5.9% of clinicians followed all recommended protocols. This lack of compliance could have significant implications for patient care and public health, particularly in the context of rising testosterone replacement therapy (TRT) prescriptions fueled by direct-to-consumer (DTC) advertising.

The study, led by Dr. Petra Pederson, Chief Resident in Internal Medicine at Scripps Clinic/Green Hospital, San Diego, evaluated the prescribing habits of 269 men treated with TRT from January 2019 to June 2023. The research team analyzed adherence to the 2018 Endocrine Society clinical practice guidelines, which stipulate that diagnoses of hypogonadism must be confirmed through two separate early morning testosterone measurements, along with appropriate follow-up testing for luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

Dr. Pederson noted that the advent of DTC advertising and the proliferation of 'low T' clinics may have distorted patient expectations, complicating the ability of healthcare providers to deliver evidence-based care. "This led us to hypothesize 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 stated during her presentation.

The data indicated a marked difference in adherence between primary care providers and specialists, with only 3.3% of primary care physicians and 11.4% of specialists meeting all criteria for guideline adherence (P = .009). The study also highlighted that 17.8% of patients had no documented low testosterone levels prior to treatment, raising concerns about the appropriateness of TRT prescriptions. For instance, while 50% of patients received follow-up testosterone measurement at three to six months, this figure dropped to 44.1% among primary care providers compared to 62.5% among specialists.

The second phase of the study involved a survey of 51 healthcare providers from Scripps, of whom 74% were primary care physicians. A significant majority (74.5%) identified DTC advertising and testosterone clinics as major public health concerns, while 76.5% called for enhanced educational tools to support proper patient management. Barriers to adherence included misinformation from advertising, pressures from patient demands, and variability in testosterone testing.

Dr. Shalender Bhasin, Professor of Medicine at Harvard Medical School and an expert in the field, remarked that the findings from this recent study were consistent with research conducted within the Veterans Administration a decade prior, which has since seen improvements in policy and practice. "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," he explained.

The fluctuating rates of TRT prescriptions have been a concern for many health professionals. Despite a decline in testosterone prescriptions following an FDA advisory in 2013 regarding cardiovascular risks, usage began to rise again around 2017. Dr. Bhasin noted that while testosterone sales are increasing, many men with testosterone deficiency remain undiagnosed, indicating a critical balance between overprescribing and underdiagnosing.

The session moderator, Dr. Ismat Shafiq from the University of Rochester, emphasized the importance of proper education for patients. Many individuals present with low total testosterone levels due to factors such as obesity or sleep apnea, which can lead to misdiagnosis if not properly evaluated. "If we check the prolactin level and we treat them, the hypogonadism will resolve. Primary hypothyroidism, too, if treated, can resolve the hypogonadism," she stated, underscoring the necessity for a thorough diagnostic approach.

In response to the study's findings, Dr. Pederson indicated that Scripps is planning a quality improvement initiative aimed at enhancing adherence to treatment guidelines. As the medical community grapples with the challenges posed by DTC advertising and TRT clinics, there is a pressing need for better education and adherence to established guidelines to ensure optimal patient care.