According to Dr. Michael Lincoff, the lead author of the study at the Cleveland Clinic, the findings provide reassurance to practitioners treating patients with hypogonadism. They can now focus more on identifying which patients will benefit from testosterone replacement therapy, without worrying about potential cardiovascular risks outweighing the benefits.
Other researchers are currently examining the data to determine how effective testosterone treatment is in relieving the symptoms of hypogonadism. These symptoms include depression, osteoporosis, anemia, loss of muscle mass, benign prostatic hypertrophy, which inhibits urine flow, and sexual symptoms.
The Food and Drug Administration (FDA) has only approved testosterone products for men with medically-induced low testosterone levels such as hypogonadism. However, doctors have the authority to prescribe medications for off-label purposes.
In 2010, the FDA reviewed testosterone replacement therapy after a clinical trial was halted due to patients experiencing heart attacks. The FDA required testosterone manufacturers to conduct a clinical trial to assess the associated risks in 2015. As a result, testosterone products now carry a black box warning about the potential increased risk of heart attacks and strokes.
Dr. Shalender Bhasin, an endocrinologist at Brigham and Women’s Hospital in Boston and a co-principal investigator of the study, is examining the trial’s results to determine if testosterone therapy truly improves sexual function and resolves other symptoms of hypogonadism. He noted that there is limited scientific evidence regarding the effects of testosterone on sexual function, with only a few randomized trials, most of which lasted between three to six months. He emphasized the significant placebo effect on sexual symptoms.
Dr. Bhasin’s ongoing studies, which have yet to be published, will investigate testosterone’s impacts on the prostate, bone fractures, and the progression of diabetes, among other factors.
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