TRT Myths Busted: The TRAVERSE Trial Changes Everything!
- David Raday
- Mar 19
- 3 min read
Testosterone Replacement Therapy (TRT) has been surrounded by controversy for years, especially regarding its impact on heart health, blood pressure, and long-term safety. But the TRAVERSE trial just changed the game—debunking outdated fears and reshaping the conversation around hormone optimization.
What did past studies get wrong?
How is TRT actually affecting cardiovascular health?
What side effects should you still watch for?
Keep reading as Elixium breaks down the latest research, how it impacts you, and what adjustments can optimize your TRT journey.
TRT Myths: What Science Got Wrong
For years, TRT myths led many to believe that testosterone therapy significantly increased the risk of heart attacks, strokes, and other cardiovascular complications. These fears were largely based on older, flawed studies that failed to account for key factors such as patient health history, dosing methods, and long-term follow-ups.
One of the most cited studies linking TRT to heart disease risk came from 2013, leading the FDA to issue a warning about potential cardiovascular risks. However, the TRAVERSE trial—a large, randomized, placebo-controlled study—has now debunked this myth by showing that TRT does NOT significantly increase the risk of cardiovascular events. (NEJM)
FDA’s Response and Labeling Changes
In light of the TRAVERSE trial outcomes, the FDA issued new labeling changes for testosterone products. The agency recommended:
Incorporating the TRAVERSE trial results into all testosterone product labels.
Removing previous warnings about increased cardiovascular risks.
Maintaining the "limitation of use" terminology for age-related hypogonadism, indicating that TRT should be reserved for men with specific medical conditions leading to low testosterone levels. (Reuters)
Persistent Concerns: Blood Pressure Implications
Despite the reassuring cardiovascular findings, concerns about TRT’s impact on blood pressure remain. Some studies have reported that TRT can lead to increased blood pressure, which is a known risk factor for cardiovascular events.
For example, research published in the Journal of Hypertension found that TRT was associated with higher office blood pressure measurements compared to placebo, and this increase was linked to higher hematocrit levels during therapy. (Journal of Hypertension)
The mechanism behind this effect may involve:
TRT-induced elevations in hematocrit, leading to increased blood viscosity and, consequently, higher blood pressure.
Fluid retention, which can contribute to temporary spikes in blood pressure.
Recognizing these risks, the FDA has mandated that testosterone product labels include warnings about potential increases in blood pressure. (Reuters)
Hematocrit Management with TRT
Testosterone therapy naturally increases hematocrit levels by stimulating red blood cell production. This can thicken the blood and increase the risk of clotting events.
Elixium’s Approach to Managing High Hematocrit:
Elixium typically prefers decreasing the injection dose or moving to a transdermal method if a patient has chronically high hematocrit.
Elixium requires labs every 3 to 6 months, depending on how long the patient has been on treatment, to closely monitor hematocrit and hemoglobin levels.
Therapeutic blood donations (phlebotomy) should be performed if hematocrit rises above 56%. Due to Colorado’s higher altitude, hematocrit and hemoglobin levels tend to be slightly elevated in the population, which must be factored into decision-making.
Elixium suggests low-dose baby aspirin (if no contraindications are present) to help prevent blood clot formation in individuals with elevated hematocrit.
Managing Fluid Retention on TRT
Fluid retention is another side effect of testosterone therapy, primarily due to:
Aldosterone stimulation, leading to increased sodium retention and fluid accumulation.
Testosterones conversion to estrogen (via aromatase), which can promote water retention.
An increase in blood volume, which can contribute to temporary swelling or bloating.
Elixium’s Approach to Managing Fluid Retention:
Water retention is typically a short-term side effect as the body adapts and tends to decrease over time.
Elixium monitors water retention through body composition scans (such as InBody scans) or other methods to track fluid shifts and ensure it is not excessive.
If fluid retention persists, Elixium may lower the testosterone dose or switch the modality (such as moving from injections to transdermal options).
Managing estrogen levels (if necessary) can help reduce excess water retention while avoiding the negative effects of excessive estrogen suppression.
Conclusion
The TRAVERSE trial has significantly advanced our understanding of TRT’s safety, particularly concerning cardiovascular risks. While older studies suggested an increased risk of heart disease and strokes, these fears have largely been debunked.
However, TRT is not without side effects, and hematocrit elevation and fluid retention remain important considerations. Elixium prioritizes personalized monitoring through routine labs, patient-specific dose adjustments, and appropriate management strategies to ensure optimal safety and effectiveness for those undergoing testosterone therapy.
As scientific research evolves, Elixium remains committed to using the latest evidence-based guidelines to provide safe, effective, and personalized hormone optimization therapy.
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