Why Testosterone Therapy Matters: A New Era in Men’s Health

For many years, the fear of heart health risks overshadowed testosterone replacement therapy (TRT), leaving men unsure of whether the treatment was worth the potential harm. With the FDA's earlier warnings about possible links to heart attacks and strokes, TRT became a controversial topic. But now, thanks to groundbreaking research from the TRAVERSE trial, the narrative has changed dramatically.

With this fresh evidence in hand, the FDA has updated its guidelines, removing the previous heart health warnings. At The Johnson Center, we've always placed your well-being at the forefront, prescribing testosterone only when it's needed. Now, with the FDA's revised stance, men can approach TRT with greater confidence and peace of mind than ever before.

Why Men Have Avoided Testosterone Replacement Therapy

For years, concerns about the impact of testosterone therapy on heart health kept many men from seeking treatment. The FDA’s previous warning about increased risks of heart attack and stroke made men hesitant. However, new research, including the TRAVERSE trial, has shown that testosterone replacement therapy (TRT) may not only be safe but could reduce the risk of heart attacks and strokes by up to 30%.

With these new findings, the FDA has updated its guidelines, removing the heart health warning. Now, with greater peace of mind, men can pursue treatment with confidence.

The Catalyst for Change: Key Clinical Findings

On February 28, 2025, the FDA announced class-wide labeling changes for all testosterone products. This decision was primarily influenced by two pivotal studies:

The TRAVERSE Clinical Trial: This extensive study evaluated the long-term cardiovascular outcomes of testosterone replacement therapy in men with hypogonadism—a condition characterized by low testosterone levels. The findings indicated no increased risk of adverse cardiovascular events in men undergoing TRT for hypogonadism.
Postmarket Ambulatory Blood Pressure Monitoring (ABPM) Studies: These studies assessed the impact of testosterone products on blood pressure. The results highlighted that certain testosterone formulations could lead to increased blood pressure, necessitating updated warnings.

The new study found that testosterone replacement therapy (TRT) does not increase cardiovascular risk. In fact, it showed TRT may reduce the risk of heart attack, stroke, and even death by 30% or more. This breakthrough finding has prompted the FDA to remove the previous heart health warnings from testosterone labels, offering a more balanced perspective for patients considering treatment.

At The Johnson Center, we’ve always prioritized safety. We never prescribe testosterone unless testing confirms low levels. If you're experiencing fatigue, low libido, weight gain, mood changes, or other symptoms of low testosterone, contact us to schedule a test. Addressing hormone imbalances can significantly improve your quality of life — and now, with updated FDA guidelines, you can pursue treatment with greater peace of mind.

Key Updates to Testosterone Product Labeling

In light of these findings, the FDA has mandated several important changes to the labeling of testosterone products:

Inclusion of TRAVERSE Trial Results: All testosterone product labels will now incorporate the outcomes of the TRAVERSE trial, providing patients and healthcare providers with comprehensive information regarding cardiovascular risks.
Retention of "Limitation of Use" for Age-Related Hypogonadism: The FDA continues to emphasize that testosterone therapy is not approved for men with low testosterone levels solely due to aging. This distinction aims to prevent misuse of TRT in populations where the benefits may not outweigh the risks.
Modification of Boxed Warnings: Previous boxed warnings about an increased risk of adverse cardiovascular outcomes are being revised. This change reflects the TRAVERSE trial's findings, which did not demonstrate a heightened cardiovascular risk for men using testosterone therapy for hypogonadism.
Blood Pressure Warnings: For testosterone products without existing blood pressure warnings, new advisories will be added. Products with completed ABPM studies indicating a risk will have product-specific information included in their labeling.

The Benefits of Testosterone Replacement Therapy (TRT)

Testosterone is more than just a hormone linked to masculinity; it plays a crucial role in overall health, vitality, and well-being. When levels of testosterone drop, especially as men age, it can lead to a variety of symptoms that negatively impact quality of life. These can include fatigue, low libido, weight gain, mood swings, depression, and a lack of motivation. Fortunately, testosterone replacement therapy (TRT) offers a solution to address these issues, providing a wide range of health benefits:

Improved Energy and VitalityMany men report feeling more energetic and active once they begin testosterone therapy. Restoring testosterone levels can help combat the fatigue and lack of motivation often associated with low testosterone, leading to a noticeable improvement in daily functioning and stamina.
Enhanced Mood and Mental ClarityLow testosterone has been linked to symptoms of depression, irritability, and difficulty concentrating. By correcting hormone imbalances, TRT can help stabilize mood, improve cognitive function, and restore mental clarity, allowing men to feel more positive and focused.
Increased Libido and Sexual FunctionTestosterone plays a critical role in sexual desire and performance. Many men with low testosterone experience a decrease in libido and erectile dysfunction. TRT can help restore sexual function, improve libido, and enhance overall satisfaction in intimate relationships.
Improved Muscle Mass and Fat DistributionTestosterone is instrumental in maintaining lean muscle mass and regulating fat distribution. When testosterone levels drop, men may experience an increase in body fat and a decrease in muscle strength. With TRT, many men see improvements in muscle mass, strength, and fat loss, contributing to better physical fitness and a more toned physique.
Bone Health and DensityTestosterone helps maintain bone density, and low levels of the hormone can increase the risk of osteoporosis and fractures. TRT can help improve bone health, reduce the risk of fractures, and support overall skeletal strength.
Better Cardiovascular HealthRecent studies, including the TRAVERSE trial, suggest that testosterone replacement therapy may have a positive effect on cardiovascular health. By improving blood circulation, reducing fat accumulation, and possibly lowering the risk of heart attacks and strokes, TRT contributes to better heart health.

With all of these benefits in mind, it’s clear that testosterone is an essential hormone for men’s health. If you're experiencing symptoms related to low testosterone, TRT could be the key to revitalizing your energy, improving your quality of life, and boosting your overall health.

Why The Johnson Center Does It Best:

At The Johnson Center, we’ve always made patient safety our top priority. We never prescribe testosterone unless extensive testing confirms low levels of testosterone. Our approach ensures that we only recommend treatment when it is truly needed, based on individual patient health profiles.

With the FDA’s new updates, men now have more confidence in seeking TRT, knowing that the risks associated with cardiovascular health have been significantly reduced. We offer comprehensive testing to assess testosterone levels and provide personalized treatment plans that align with each patient’s needs and health goals. If you're experiencing symptoms like fatigue, low libido, weight gain, or mood changes, we encourage you to schedule a test with us to determine if TRT might be right for you. Addressing hormone imbalances can significantly improve your quality of life — and now, with the latest research supporting TRT's safety, you can pursue treatment with peace of mind.

For more information on TRT click here to contact us or call 276-235-3205 to schedule your complimentary discovery call.

The Johnson Center for Health services patients in-person in our Blacksburg and Virginia Beach / Norfolk locations. We also offer telemedicine for residents of Virginia and North Carolina!