What a fascinating time this last year has been for the field of testosterone therapy! But before I get started, I want to mention that it is not too late to register for the annual meeting of the Androgen Society, which will be held, May 29-30,2024, in Boston. This is an incredible event, with lectures and debates by many of the leading testosterone researchers from around the world. Discounted registration is available until May 8, 2024, so hurry! Learn more about the Androgen Society Annual Meeting.
So, why do I write that it’s been a fascinating time for T therapy? The TRAVERSE trial provided the medical community with 7 publications in total, beginning with the reassuring cardiovascular (CV) results published in the New England Journal of Medicine in June 2023. The other six publications showed: significant sexual benefits for T therapy compared to placebo; no increase in total or high-risk prostate cancer with T therapy, nor increase in voiding symptoms; improvement in depressive symptoms; greater resolution of unexplained anemia; absence of greater reduction in bone fractures for men that received T therapy; and no greater impact on diabetes mellitus.
As a reminder, TRAVERSE was by far the largest randomized controlled trial (RCT) involving T therapy ever, involving over 5000 men randomized to T gel or placebo gel, with a mean follow-up of 33 months. By comparison, the two previous large RCTs were the Testosterone Trials with 790 men and the T4DM trial with just over 1000 men.
In my opinion, the most important of these results were those addressing CV and prostate cancer risks. The design of those two publications was rigorous and the results were “clean” and therefore not vulnerable to criticisms that there was some “signal” of greater risk because of a numerically greater number of adverse events in the T arm, or some other failing of the studies. Specifically, the rate of major adverse CV events (MACE) in the CV trial was 7.0% for the TTh group and 7.3% for the placebo group. For prostate cancer, the total number of cancers were nearly identical, with 12 in the T arm and 11 in the placebo arm. High-grade cancers were remarkably few, with just 5 in the T arm and 3 in the placebo arm.
These two issues – prostate cancer and more recently CV risk – have historically been the biggest hurdles to overcome for those who see T therapy as an important therapeutic treatment for men with T deficiency (hypogonadism). With both of those concerns now definitively proven incorrect, and with both sexual and non-sexual benefits established by TRAVERSE and prior RCTs, this should be a new era for the use of T therapy in men with T deficiency.
We’ll see if that happens. Skeptics of TTh abound, and there is also a current tendency to view every new study as having equal weight, so TRAVERSE may be end up being regarded by consumers of medical research as carrying no more weight than the next published study they read about on Medscape or other media, which may be an observational study of questionable design, but with a provocative title.
Best regards,
Abe Morgentaler, MD