How Safe is Testosterone Replacement Therapy?

As men age, their testosterone levels decrease. By the time a man reaches 40 years of age, his testosterone level typically begins to decrease by approximately 1 percent each year.

Some of the changes associated with that drop include lower sex drive, increased body fat, decreased bone density, loss of body hair, sleep disturbances, and lower energy levels. Many men may also suffer from a loss of self-confidence or motivation. There is also a higher risk of depression and memory loss.



One solution that physicians may arrive at for their male patients struggling with some of these symptoms is testosterone replacement therapy. There is still much controversy and debate over how effective – and safe – testosterone replacement therapy is.

And just two years ago, the Food and Drug Administration (FDA) issued warning about the possible dangers associated with cardiac side effects and testosterone replacement.  The recent release of the conclusion of multiple studies appears to not offer any solutions to those debates.

The Testosterone Trials (TTrials) results were published in JAMA, the journal of the American Medical Association and JAMA Internal Medicine. In all five studies, participants were given either the testosterone AndroGel or a placebo.

All of the 788 men who took part in the studies were 65 years of age or older and had below normal level of testosterone at the start of the studies. The studies took part in 12 different locations across the country.    

The overall results revealed that the men who were given the AndroGel measured higher levels of testosterone at the end of the study. These participants showed improvements in both bone density and bone strength.

Men who had unexplained anemia showed improved levels of iron in their blood. Participants also showed significant improvement in sexual desire and function,

In the TTrials’ Bone Trial, 189 men participated. The subjects using the AndroGel had a significant improvement in their hip bone density, bone strength, and lumbar spine.

The research team did not find any significant improvement in the cognitive or memory skills in the 493 men who participated in the TTrial the Cognitive Function Trial.

Risk of Heart Disease and Stroke

The general consensus of the researchers involved in the studies was that the risks of testosterone replacement therapy may far outweigh any benefits it may offer.

Unfortunately, they drew the wrong conclusions.



In the TTrials’ Cardiovascular Trial, the study team discovered an increase in plaque buildup which they associated with heart disease. Although there was an increase in non-calcium plaque and total plaque, these findings do not correlate with cardiovascular risk. The Calcium Score, however strongly correlates with cardiovascular risk and was reduced in the testosterone user’s group.

Low Calcium Scores are associated with a statistically significant reduction the risk of heart disease, heart attack and stroke. This is an extremely significant finding and supports the hundreds of previous studies which confirm the protective benefits of testosterone therapy.

Upon hearing of the results of the studies, Dr. Edward Jacobson commented, “I find the results of these testosterone replacement studies, as well as other studies which have been conducted, extremely positive and beneficial for patients who may be dealing with medical issues, especially cardiac, associated with low testosterone.”