WASHINGTON – An industry-backed study of oral testosterone replacement (TRT), testosterone undecanoate (TU, Jatenzo brand name) finds to be an effective, long-term treatment for men with low testosterone levels, with no evidence liver toxicity. The results are presented almost at ENDO 2021, the annual meeting of the Endocrine Society.
TST is currently available in a number of management modalities, including transmissible gels, transdermal gels and intramuscular injections.
“For many men with low testosterone levels, an oral option is best to avoid issues related to other methods of administration, such as injection site pain or transfer to partners and children,” said lead researcher Ronald S. Swerdloff, MD, of the Lundquist Research Institute in Torrance, California. “Prior to TU approval, methyl-testosterone was the only orally approved TST in the United States, which was known to be associated with severe chemical liver damage.”
The US Food and Drug Administration approved TU in March 2019, and the drug was released commercially in February 2020.
Swerdloff performed a safety and efficacy analysis after two years of oral TU capsule administration in men with low testosterone levels. There were two parts to the study. The first study included men ages 18 to 75 with low testosterone levels that persisted for 12 months. After the first year, 86 males enrolled in the second study, which lasted another year.
Over two years, TU kept total testosterone levels in the normal range, with a safety profile broadly consistent with other approved testosterone products. There was no evidence of liver toxicity. There was a small but statistically significant increase in prostate-specific antigen (PSA), prostate-secreted protein, and hematocrit (HCT), which measures red blood cell levels. Swerdloff noted that these increases are monitored by other types of TST, regardless of the administrative methods. The drug had minimal effects on “bad” LDL cholesterol, while lowering “good” HDL cholesterol, as is common with other TRT formulas.
“Our study finds that TU is an effective oral treatment for men with low testosterone levels and has a safety profile that is consistent with other approved testosterone products, without the benefits of non-oral administration methods. , “said Swerdloff.
Clarus Therapeutics supported the research.
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