Summary
A patient-friendly breakdown of key takeaways from the FDA’s latest expert panel on testosterone replacement therapy, including safety, prostate cancer myths, and why testosterone is an important marker of men’s overall health and longevity.
This article reviews key takeaways from a recent FDA expert panel on testosterone replacement therapy (TRT), translating emerging science into what it may mean for men’s long-term health, disease prevention, and quality of life.
On December 10, 2025, the U.S. Food and Drug Administration (FDA) hosted a variety of leading experts on testosterone replacement therapy (TRT) for men, including world-renowned urologists, primary care physicians, researchers, pharmacists, and clinicians on the front lines treating male patients every day. The main focus of the panel was to discuss the latest scientific evidence on TRT, assess potential health risks and remove outdated warnings, learn about different treatment options, and hear the recommendations from top clinical experts on the evolving science in an effort to modernize regulatory oversight and update evidence-based practice standards. While listening to this historic two-hour roundtable, there was no shortage of relevant information regarding TRT and its importance to men’s health. But what stood out to me the most was the recurring theme amongst all of the speakers that testosterone levels are one of the best markers of a man’s overall health.
Key Takeaways: What Men Should Know About Testosterone Therapy
- Testosterone levels are closely linked to overall health, not just energy, libido, or muscle mass.
- FDA experts reviewed current evidence and found no increased risk of prostate cancer associated with testosterone therapy.
- Low testosterone is associated with higher risks of cardiovascular disease, diabetes, depression, bone loss, and early mortality.
- Testosterone therapy may play a role in disease prevention and health optimization when medically prescribed and properly monitored.
- Routine screening for low testosterone is often overlooked but may be an important part of preventive care for men.
Why the FDA Revisited Testosterone Therapy
For patients, this reframes testosterone from being viewed solely as a hormone related to energy or libido and instead positions it as a meaningful marker tied to long-term health and longevity.
Testosterone as a Marker of Overall Men’s Health
I was first introduced to this concept by Dr. Abraham Morgantaler last January when Dr. Couri and I attended a medical conference on Testosterone Therapy and Sexual Dysfunction (Harvard University, 2025) in Orlando, FL. Dr. Morgentaler, a board-certified urologist and Blavatnik Faculty Fellow in Health and Longevity at Harvard University, has dedicated his life to men’s health and treating testosterone deficiency. During the conference’s keynote presentation, The Importance of Testosterone in Men’s Health, he stated that a man’s testosterone level is arguably the best indicator of his overall health because of its impact on almost every major system in a man’s body. He proposed that there is no other biomarker that is associated with or predictive of as many of the significant health issues facing men today, including diabetes, obesity, metabolic syndrome, low bone density, anemia, sexual dysfunction, depression, dementia, and mortality (Harvard University, 2025). While speaking during the U.S. Food and Drug Administration (2025) roundtable, he focused on the safety of testosterone and debunking the myth that testosterone replacement increases the risk for prostate cancer or the risk of progression or recurrence in men with a history of prostate cancer. He provided data showing the rate of TRT increased sixfold from 2002 to 2013, while the incidence of prostate cancer did not increase during that same time. He also provided evidence from four randomized controlled trials comparing rates of prostate cancer in men using TRT versus placebo that showed no difference between the two groups. These findings are demonstrated in the graph below.
Does Testosterone Increase Prostate Cancer Risk?
Conversely, there is evidence that TRT actually decreases the risk of prostate cancer, citing a recent Medicare study of over 500,000 men showing a 16% reduced risk. Dr Morgentaler ends by suggesting the warnings and contraindications regarding prostate health should be removed from all testosterone replacement labels given the latest scientific evidence and decades of his personal experience treating men with prostate cancer.
Testosterone, Cardiovascular Health, and Chronic Disease Risk
During the opening lecture of the U.S. Food and Drug Administration (2025) roundtable, Dr. Mohit Khera, a board-certified urologist, medical director, professor, and associate director at Baylor Infertility and Sexual Medicine fellowship program, describes how low testosterone levels in men negatively impact health, reduce quality of life and increase risk of mortality. He goes on to give statistics associated with men who have low testosterone levels compared to men with normal levels, including:
- 17% more likely to have cardiovascular disease.
- 52% more likely to have diabetes.
- 69% more likely to have obesity
- 50% more likely to break a bone.
- 86% more likely to suffer from depression
- 2x as likely to have a risk of all-cause mortality than men with normal testosterone levels.
These statistics help explain why testosterone deficiency is increasingly viewed as a whole-body health issue, not only a quality-of-life concern.
Because of the above risks, he feels testosterone should not just be pursued to improve libido and increase muscle mass, but instead should be thought of as a tool that can help with disease prevention and overall health optimization. Similarly, Dr. Martin Miner, a board-certified urologist, professor, and current president of the Androgen Society, discusses a study published by Wittert, et al, (2021) called the T4DM, which was a two-year trial of over 1,000 men between the ages of 50-74 all with visceral adiposity and either at increased risk for or newly diagnosed with type 2 diabetes. The men were either treated with testosterone injections plus lifestyle modifications or placebo plus lifestyle modifications. The findings showed that the men treated with TRT plus lifestyle modifications had a reduced prevalence of type 2 diabetes by 41% and another 13% of men reversed their type 2 diabetes compared to those in the placebo plus lifestyle group. This is a significant finding given the epidemic of obesity and type 2 diabetes in our country and the health implications that are associated with them.
Testosterone Therapy and Type 2 Diabetes Prevention
These findings underscore why men are increasingly looking at testosterone therapy as part of a comprehensive, medically supervised approach to metabolic health—alongside lifestyle changes.
Why Testosterone Screening Is Often Missed in Preventive Care
Dr. Helen Bernie, a board-certified urologist whose entire practice is dedicated to men’s health, discussed how low testosterone in men can be an indicator of poor health and is associated with higher rates of early death and cardiovascular disease, the number one killer of men. Despite this risk, it is still something we do not routinely screen for. As a result, millions of men go undiagnosed and untreated, leading to increased risk of preventable diseases. A serum testosterone level is one of the most informative yet underutilized biomarkers in men’s health, and Dr. Bernie recommends it should be part of routine screening in preventative care to improve quality of life and increase longevity. She has personally seen how addressing this important biomarker in her male patients changes their lives. They have improved energy, increased confidence, can think more clearly, have better relationships, and, most importantly, it gives them their dignity back. Testosterone replacement therapy can be just as beneficial for disease prevention as for improving quality of life, regaining self-confidence, and increasing longevity (U.S. Food and Drug Administration, 2025).
How To Schedule
New patients are always welcome. To learn more about male hormone therapy at the Couri Center, or to schedule a consultation online, use the below form or call the Couri Center at (309) 692-6838.
Lauren Ponder
About the Author
Lauren Ponder, MSN, APN, FNP-C, is an Advanced Practice Registered Nurse at the Couri Center. She earned her BSN, RN, from Saint Louis University in 2010 and worked in Trauma, Surgical, and Burn ICU at Barnes Jewish Hospital in St. Louis before returning to Peoria. She later worked in Trauma Surgical ICU at OSF Saint Francis Medical Center and received her MSN, FNP, from Saint Francis Medical Center College of Nursing in December 2019. She completed gynecological training at Illinois Cancer Care (Gynecology-Oncology division) and with Dr. Michele Couri at the Couri Center. In addition to routine gynecology, Lauren is passionate about integrative wellness and hormone replacement therapy. Couri Center
Disclaimer: This article is for educational purposes only. Nothing here should be considered medical advice. Please consult your healthcare provider or schedule with the Couri Center if you need personalized care.
References:
Harvard University. (2025, January 17–18). Testosterone therapy and sexual dysfunction [Course]. Harvard Professional & Lifelong Learning. https://pll.harvard.edu/course/testosterone-therapy-and-sexual-dysfunction-1
U.S. Food and Drug Administration. (2025, December 10). FDA Expert Panel on Testosterone Replacement Therapy for Men [Video]. YouTube. https://www.youtube.com/live/BdAawJmQ9Fs?si=AflERnQv3yw2wetB
Wittert, G., Bracken, K., Robledo, K. P., Grossmann, M., Yeap, B. B., Handelsman, D. J., Stuckey, B., Conway, A., Inder, W., McLachlan, R., Allan, C., Jesudason, D., Ng Tang Fui, M., Hague, W., Jenkins, A., Daniel, M., Gebski, V., & Keech, A. (2021). Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): A randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. The Lancet Diabetes & Endocrinology, 9(1), 32–45. https://doi.org/10.1016/S2213-8587(20)30367-3