The Department of Health and Human Services announced plans on June 18 to update label information for testosterone replacement therapy products. The proposed changes would remove restrictions on prescribing the therapy for age-related hypogonadism, revise warnings about prostate cancer risk, and update safety information about benign prostatic hyperplasia, which is commonly known as an enlarged prostate.
According to Healthline, current FDA-approved testosterone replacement therapy products may only be prescribed for forms of hypogonadism with specific genetic or structural causes. Age-related hypogonadism refers to the gradual decline in testosterone that can occur with aging rather than from an identifiable medical condition. The proposed changes would lift the restriction tied to that condition.
"During Men's Health Month, we are putting science back at the center of men's healthcare," HHS Secretary Robert F. Kennedy Jr. said in the announcement. "By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men."
The announcement follows a December 2025 meeting of FDA experts, during which the panel signaled broad support for expanding access to testosterone replacement therapy. Federal officials said the proposed changes reflect a growing body of evidence supporting the safety and effectiveness of the therapy when appropriately prescribed and monitored.
A central piece of that evidence is the TRAVERSE trial, a large study involving more than 5,200 males. According to HHS, the trial found no meaningful increase in the risk of major adverse cardiovascular events, including heart attack and stroke, among males receiving testosterone replacement therapy. Based on its review of the TRAVERSE findings and other available evidence, the FDA concluded that the existing limitation is no longer warranted.
Men's health experts interviewed by Healthline agreed that risks associated with testosterone replacement therapy related to cardiovascular disease, prostate cancer, and enlarged prostate have been overstated. The proposed labeling revisions focus specifically on those three areas.
Federal officials framed the changes as a shift toward aligning label information with the most current scientific evidence. For patients, the proposed updates could expand access to treatment while also clarifying risks based on up-to-date research. No final implementation date has been announced.
