Assessing Adherence to Guideline-Based Diagnosis and Treatment of Male Hypogonadism in the Age of Direct-To-Consumer Advertising

madman · Saturday at 12:47 PM

Author Block: Petra E. Pederson, MD, PhD1, Jeremy Winkelman, MD1, Michelle Wong, MD1, Leah Puglisi, MS2, Matthew Jason Levine, MD, FACE3. 1Scripps Clinic/Scripps Green Hospital, La Jolla, CA, USA, 2Scripps Hub Academic Research Core (SHARC)/Scripps Health, San Diego, CA, USA, 3Scripps Clinic/Division of Endocrinology, La Jolla, CA, USA.
Disclosure Block: P.E. Pederson: None. J. Winkelman:None. M. Wong: None. L. Puglisi: None. M.J. Levine: None.

Background

Prescriptions for testosterone replacement therapy (TRT) for male hypogonadism have increased over recent decades in association with increased direct-to-consumer advertising (DTCA). Despite publication of evidence-based guidelines in 2018, inappropriate treatment by online and “boutique” clinics remains prevalent. Our study aims to assess adherence to guidelines by primary care providers (PCPs) compared to specialists (endocrinologists and urologists) within our health system and identify the provider perceived prevalence of this problem and barriers to providing evidence-based care.

Methods

A retrospective chart review identified 269 adult male patients initiated on TRT between 2019 and 2023. Guideline adherence, including confirmatory testing with two low AM total or free testosterone levels and testing for etiology, was compared between PCPs and specialists. In addition, a survey of providers was conducted regarding their experiences with TRT. Comparisons between groups were made using chi-square test of independence or Fisher’s Exact test.

Results

Of the 269 TRT prescriptions identified, 181 (67.3%) were from PCPs, 67 (24.9%) urologists, and 21 (7.8%) endocrinologists. Only 25 (9.3%) patients had two low AM testosterone levels prior to initiating TRT, with no significant difference between PCPs and specialists (7.2% vs 13.6%, p = 0.359). PCPs were more likely to initiate TRT without any low testosterone levels compared to specialists (21.5% vs 10.2%, p = 0.023). Specialists ordered LH and FSH testing more than PCPs, however the difference was not significant (33% vs 23.2%, p = 0.089; 27.3% vs 19.3%, p=0.14). Among specialists, endocrinologists obtained two low AM testosterone levels prior to TRT initiation more often than urologists (42.9% vs 4.5%, p = 0.0012), and similarly for LH and FSH (85.7% vs 16.4%, p = 0.001; 66.7% vs 14.9%, p < 0.001). Survey data from 51 providers revealed 100% of providers had at least one TRT request in the last 6 months and 74.5% felt DTCA was a public health issue.

Conclusion

This study suggests that most patients did not receive appropriate workup before starting TRT, unnecessarily exposing them to potential adverse effects. The disparity between specialists and PCPs suggests a knowledge gap among providers. Striking differences were also noted between urologists and endocrinologists, which may be due to the greater volume of patients with sexual dysfunction presenting to urology compared to endocrinology. Our survey revealed most providers have concerns regarding DTCA and the prevalence of misinformation regarding TRT. A limitation of this study is its restriction to one region and health system. The effect of DTCA on TRT prescribing practices is still unclear, requiring further research. Regardless, this data can guide quality improvement initiatives on appropriate laboratory testing to promote safe and evidence-based care.

Thread 'Reevaluating the threshold for low total testosterone'

May 12, 2025

Reevaluating the threshold for low total testosterone

In this podcast, Adith Arun from the Yale New Haven Hospital Center for Outcomes Research and Evaluation, and a third year medical student at the Yale School of Medicine, discusses a letter to the editor, “Reevaluating the threshold for low total testosterone,” published in the May 2025 issue of...

myadlm.org

Bob Barrett:

Well, finally, looking ahead, what kind of research do you think is needed to ensure that guidelines and clinical practices align with the latest evidence on testosterone measurement?

Adith Arun:

Yeah, that’s a great question, Bob. And I think there are a few different cutoffs out there by different bodies, which you highlighted earlier in our conversation. And I think the first step is to try to...

madman · Saturday at 1:14 PM

More T is better SHEEP mentality BULLS**T!

Where have we heard that before!

LMFAO!

The blame falls on many of those shady dime a dozen run of the mill so called T-clinics amping men up on high dose T from the get-go!

All the half wits stinking up those so called HRT/men's health forums loaded with those blast n cruizzzers.....BRUH F**KING DICKULOUS!

Those so called gurus polluting the net!

Complete F**KING S**T SHOW!

Ismat Shafiq MD

* She also noted that many patients mistakenly believe that more testosterone is better. “We need to educate them.

Adherence to Male Hypogonadism Treatment Guidelines Is Low

In the era of direct-to-consumer advertising, inappropriate testosterone prescribing is common, study finds.

www.medscape.com

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.”

madman · Saturday at 1:19 PM

Thread 'American men are hungry for injectable T: A legion of new health clinics are serving it up'

Jul 12, 2025

As I have always stated many of those dime a dozen run of the mill T-clinics are overmedicating men on T from the get-go!

Dishing out those high doses let alone treating some men who do not truly need to be on T!

All those bumass so called HRT/men's health forums let alone so called gurus stinking up the net are also to blame for that more T is better mentality!

Herd f**king mentality, complete sheep show.....I mean S**T SHOW!

https://www.economist.com/united-states/2025/07/08/american-men-are-hungry-for-injectable-testosterone

madman · Saturday at 1:20 PM

Thread 'Testosterone and the Future of Men’s Health'

Jul 16, 2025

This is a gem!

Dr. Mulhall knows where it's at when it comes to the methods/assays used for testing free testosterone!

Equilibrium Dialysis is whrere it's at!

In this landmark episode of Pearls & Perspectives, host Amy Pearlman, MD, sits down with one of the world’s foremost experts in sexual medicine, John P. Mulhall, MD, of Memorial Sloan Kettering Cancer Center in New York, New York. Known for shaping the way clinicians understand and manage testosterone deficiency and male sexual dysfunction, Mulhall offers an unfiltered, evidence-based deep...

madman · Saturday at 1:20 PM

Thread 'Importance of free testosterone measurement in assesssing androgen disorders'

Jun 15, 2025

As usual Nelson's house is where it's at!

Importance of free testosterone measurement in assessing androgen disorders

Thursday, March 27, 2025 at 1:00 PM Eastern Daylight Time.

event.on24.com

Testosterone imbalances affect men, women, and children differently. In males, testosterone deficiency (hypogonadism) can lead to low libido, fatigue, and muscle loss, while excess may contribute to aggression and cardiovascular risks. In females, testosterone excess (hyperandrogenism), often associated with polycystic ovary syndrome (PCOS) or adrenal disorders, can cause excess hair growth, weight gain, and menstrual irregularities. In children...

madman · Saturday at 1:26 PM

Where do those natty outliers that fall in the 95th percentile sit?

This is a F**KING short-lived daily peak to boot!

LMFAO!

Thread 'Age-stratified reference ranges for directly measured (ED LC-MS/MS) serum free testosterone in healthy men'

May 11, 2024

Just to be clear up any confusion this is Fiers camps data for mFT reference ranges not the harmonized reference range being worked on by the CDC.

*Serum samples were analyzed from healthy men participating in the SIBLOS/SIBEX and EMAS studies, both population-based cohort studies

* mFT levels were measured in 867 men using ED LC-MS/MS as previously reported (1). Subsequently, 95% reference ranges were determined using the non-parametric method

Reference: 1. Fiers T, Wu F, Moghetti P, Vanderschueren D, Lapauw B, Kaufman JM. Reassessing Free-Testosterone...

*We established mFT reference ranges for healthy men aged 18 to 69 years

We present 95% mFT age-stratified reference ranges

Age category (years)	Median mFT (ng/dl)	95% mFT reference range (ng/dl)
18-29 (n=140) 30-39 (n=252)	12.0 9.8	6.7-25.3 4.9-18.5
40-49 (n=207)	8.1	4.3.14.2
50-59 (n=146)	7.1	3.8-12.8
60-69 (n=126)	6.4	3.4-11.7
70-79 (n=125)	5.6	2.7-8.7

*The gold-standard for the determination of FT levels is considered to be directly measured free testosterone (mFT) using equilibrium dialysis followed by mass spectrometry (ED LC-MS/MS). However, no widely accepted reference ranges are available for this clinical parameter. We established mFT reference ranges for healthy men aged 18 to 69 years

*Serum samples were analyzed from healthy men participating in the SIBLOS/SIBEX and EMAS studies, both population-based cohort studies

* mFT levels were measured in 867 men using ED LC-MS/MS as previously reported (1).

Reference: 1. Fiers T, Wu F, Moghetti P, Vanderschueren D, Lapauw B, Kaufman JM. Reassessing Free-Testosterone Calculation by Liquid Chromatography–Tandem Mass Spectrometry Direct Equilibrium Dialysis. J Clin Endocrinol Metab. 2018;103(6). doi:10.1210/jc.2017-02360

In the current study, we used a state-of-the-art direct ED method to reassess FT in sets of representative serum samples. This method takes advantage of the ability of a highly sensitive and accurate measurement of T by liquid chromatography–tandem mass spectrometry (LC-MS/MS) to reliably measure the low FT concentration directly in the dialysate after ED. This more straightforward method avoids potential sources of inaccuracy in indirect ED, such as those resulting from tracer impurities or from measures to limit their impact (e.g., sample dilution). We then used the measured FT results to re-evaluate some characteristics of two more established and a more recently proposed calculations for estimation of FT.