Written by Keen Meds · Reviewed by Licensed Clinical Providers · March 1, 2026
Key Insight: US testosterone prescriptions tripled between 2001 and 2011, from approximately 1.3 million to 3.76 million — driven largely by direct-to-consumer advertising and broader recognition of testosterone deficiency as a treatable condition.
The story of testosterone therapy in the United States over the past 25 years is not simply a story about a medication. It is a story about how diseases get defined, how pharmaceutical marketing shapes clinical practice, how regulatory actions affect patient behavior, and how technology changes who can access medical care.
In 2000, testosterone replacement therapy was a specialty treatment prescribed primarily by endocrinologists and urologists for men with confirmed hypogonadism. By 2013, it had become one of the most prescribed medications in the country. By 2016, prescriptions had declined sharply following safety warnings and media coverage. And by 2025, telehealth had transformed the landscape again, making evaluation and treatment accessible to men who could not or would not seek care in a traditional clinic setting.
The Pre-Gel Era: When TRT Was a Specialty Treatment (Pre-2000)
Before AndroGel's approval in 2000, testosterone replacement therapy was managed almost exclusively with injectable formulations and, to a lesser degree, scrotal and non-scrotal patches. Treatment was concentrated in endocrinology and urology practices because the management of hypogonadism required familiarity with testosterone lab interpretation, injection protocols, and monitoring for polycythemia and other known effects.
The patient population receiving TRT in the 1990s was primarily men with confirmed primary or secondary hypogonadism: men who had undergone orchiectomy, men with Klinefelter syndrome, men with pituitary disease, or men with testosterone levels severely below normal range. The treatment was considered appropriate for a relatively narrow clinical population.
Pharmaceutical direct-to-consumer advertising of testosterone was essentially absent during this period. Injectable testosterone was a generic commodity with no patent protection, and patch products had limited commercial scale. There was no commercial incentive to build a mass market for testosterone therapy.
The Gel Era and the "Low T" Campaign (2000-2013)
The FDA approval of AndroGel 1% in February 2000 changed the commercial calculus. AndroGel was a branded, patented product with a meaningful profit margin and a manufacturer -- initially Solvay Pharmaceuticals, later acquired by AbbVie -- with resources to invest in expanding the market.
The commercial strategy that followed was notable for its scale and its framing. Rather than marketing narrowly to endocrinologists who managed hypogonadism, the pharmaceutical industry promoted the concept of "Low T" or "andropause" -- the idea that a broad range of symptoms experienced by middle-aged and older men, including fatigue, reduced libido, increased body fat, and mood changes, could be attributable to declining testosterone and treated with TRT.
Television commercials, magazine advertisements, and symptom-screening websites encouraged men who felt fatigued or sexually disinterested to ask their doctors about their testosterone levels. The campaigns were successful by any commercial measure. Between 2001 and 2011, testosterone prescriptions in the United States grew from approximately 1.3 million to 3.76 million annually. AbbVie's AndroGel alone generated over two billion dollars in annual sales by 2013.
Primary care physicians, not specialists, wrote a large proportion of the new testosterone prescriptions. The expansion of TRT into primary care was enabled by the relative simplicity of gel application and monitoring compared to injections.
The Contraction: Safety Concerns and Market Decline (2013-2018)
The commercial expansion of TRT ended abruptly beginning in 2013. The publication of Vigen et al. in JAMA in November 2013, followed by Finkle et al. in PLoS ONE in early 2014, generated significant media coverage linking testosterone therapy to heart attacks and strokes. The coverage was disproportionately alarming relative to the methodological limitations of the studies involved, but it reached patients and clinicians broadly.
The FDA's 2014 announcement of a safety review, followed by the March 2015 addition of black box cardiovascular warnings to all testosterone products, marked the regulatory inflection point. Clinicians who had been prescribing testosterone in a primary care context became cautious. Some stopped prescribing it altogether pending clarification of the safety question.
By 2016, testosterone prescription volumes had declined substantially from the 2013 peak. AbbVie faced legal challenges related to its AndroGel marketing practices. The "Low T" framing became associated in media coverage with aggressive pharmaceutical marketing rather than legitimate clinical practice.
This contraction had clinical consequences. While some of the prescriptions written during the expansion period were clinically unjustified, many men with genuine hypogonadism who had been appropriately treated were caught in the regulatory and media backlash, either stopping treatment or having difficulty finding physicians willing to prescribe.
Recovery and Normalization (2018-2023)
Between 2018 and 2023, prescription volumes gradually recovered as the scientific evidence accumulated and clinical guidelines were updated. The Endocrine Society's 2018 clinical practice guidelines provided a more rigorous framework for hypogonadism diagnosis and treatment, emphasizing the importance of confirmed low testosterone on two separate measurements, documented symptoms, and appropriate monitoring.
Multiple meta-analyses and large observational datasets published during this period largely failed to confirm the cardiovascular signal from the 2013-2014 studies, and the weight of epidemiological evidence began to favor a neutral or potentially beneficial cardiovascular effect of testosterone therapy in appropriately selected men.
The five years from 2018 to 2023 were also the period of significant telehealth expansion, catalyzed by the COVID-19 pandemic and subsequent regulatory changes that allowed telehealth prescribing for a broader range of conditions.
The Telehealth Transformation (2020-Present)
Telehealth has materially changed who can access testosterone evaluation. The traditional pathway required finding a physician knowledgeable about hypogonadism, obtaining a referral, waiting for an appointment, having blood drawn, returning for follow-up results, and managing the ongoing prescription and monitoring relationship. For men in rural areas, men without specialist access, or men who found the medical system difficult to navigate, this pathway was a significant barrier.
Telehealth platforms have compressed this pathway into a sequence that can be completed from home: an initial online consultation, at-home or local lab testing, a follow-up telehealth visit to review results, and -- if clinically appropriate -- a prescription delivered to the patient's door.
The market today reflects a combination of increased access, improved clinical standards, and a safety profile that is better characterized than at any prior point in TRT history. The TRAVERSE trial's 2023 results, and the March 2025 removal of the cardiovascular black box warning, have removed the major regulatory uncertainty that constrained clinical prescribing through much of the prior decade.
Understanding Your Testosterone Today
The market history of testosterone therapy reflects broader patterns in how medicine, pharmaceutical marketing, regulation, and technology interact over time. Today's environment -- with telehealth access, at-home testing, and the clearest safety evidence in the history of TRT -- offers appropriately evaluated patients better options than at any prior point.
Keen Meds connects you with licensed clinical providers for a telehealth evaluation and lab review. If your testosterone is clinically low, you may qualify for a prescription for Testosterone Spray Rx -- a needle-free transdermal testosterone program.
