A new wave of companies is making testosterone easily available online. The authors of a recent study say there could be risks to patients.

• A recent study reviewed seven companies that prescribe testosterone therapy online.
• It found that none of the platforms followed guidelines for prescribing testosterone.

A new wave of companies is making testosterone, the primary sex hormone in men that increases muscle mass and affects fertility, easier to get.

According to the Cleveland Clinic, about 2% of men have low levels of testosterone, which can lead to symptoms including hot flashes, reduced libido, and reduced strength and endurance, though symptoms can vary between patients. But stigma prevents some people from seeking testosterone replacement therapy, also called TRT, from doctors in-person.

Enter direct-to-consumer telehealth companies, like Regenx, Defy Medical, TRT Nation, and Hone. These companies say that they make treatment more accessible for people who already suspect they have low testosterone. Patients can discuss their concerns with a provider, and then get testosterone mailed to their door if they are eligible.

But, according to one study published on December 5, some services may be prescribing testosterone to people who don't need it—without telling them about the risks it can pose.

A new study shows that DTC companies do not all follow medical guidelines

The new study encourages patients looking to get testosterone therapy online to educate themselves before taking the leap.

The study, published in JAMA Internal Medicine by researchers from Northwestern University Feinberg School of Medicine, Case Western Reserve University School of Medicine, and Northshore University HealthSystem, used a secret shopper to pose as a prospective patient. They tested seven direct-to-consumer healthcare companies and found that none of them followed every guideline set by the Endocrine Society and the American Urological Association for prescribing testosterone and educating patients. The study did not name the companies they tested.

According to Joshua Halpern, an assistant professor of urology at the Northwestern University Feinberg School of Medicine and one of the authors of the study, their aim was "to raise awareness for patients who are thinking about initiating care for low testosterone, to really encourage them to see local providers and educate themselves regarding the potential risks and benefits of testosterone therapy."

Testosterone replacement therapy can come with side effects, like an increase in red blood cells, infertility, and potentially heart issues.

The study showed that testosterone therapy companies may prescribe testosterone to people who shouldn't get it

The secret shopper in the study was a 34-year old man who reported a low libido and low energy levels, and expressed that he was interested in maintaining fertility. The companies had the patient consult with either a nurse practitioner, a physician's assistant, or a nonmedically licensed individual in one case. He told the companies that he had a testosterone level of 675 nanograms per deciliter — well above the measurement of 300 nanograms per deciliter that the American Urological Association advises is reasonably considered low testosterone.

"According to some of our societal guidelines, like guidelines from the American Urological Association, he would not have been an appropriate candidate to receive testosterone therapy," Halpern told Insider.

Only one of the companies asked the shopper about his fertility desires or cardiovascular history. None of them discussed all the risks of the therapy. The study found that six out of seven of the companies tested offered testosterone therapy to the shopper. One company did not offer testosterone, but it still did not fully adhere to the American Urological Association guidelines when talking with the patient about his desires for future fertility.

The study was not meant to evaluate companies prescribing testosterone for gender affirming hormone therapy, which is a different process than testosterone replacement therapy.

The study emphasizes that consumers should talk to a primary care provider about their testosterone concerns

"I think we were surprised by the number of platforms that offered the secret shopper testosterone in particular, given how normal his level was," Halpern said.

One of the limitations of the study was that there was only one secret shopper, and the study did not test whether they would have responded differently if the patient presented different symptoms or concerns. Additionally, the study notes the small sample size of companies they tested.

While Halpern told Insider that he doesn't have any evidence for patients being harmed due to companies failing to follow guidelines, he also said that "there certainly is a chance that that could lead to suboptimal outcomes and potentially a little bit more risk for patients who are being treated in this way."

Halpern said that he would encourage patients who are worried about their testosterone levels to talk to a primary care provider, as well as a urologist or endocrinologist, and to make sure that they educate themselves before starting treatment.