Trials show safety and efficacy of Rextoro in Hypogonadism-Clarus Therapeutics

Clarus Therapeutics has presented Phase III clinical data from studies that support the safety and efficacy of Rextoro (testosterone undecanoate) for Testosterone-replacement therapy in men with Hypogonadism. In the first study, both trials recruited hypogonadal men age 18-75 years old into open-label, multicenter, dose-titration trials. Trial I was a randomized, active-controlled, 2-arm, 12-month study in 325 hypogonadal men. Participants were randomized to either Rextoro (n=162) or 1% AndroGel (n=163), a commonly prescribed T-replacement therapy. Trial II was a single-arm 114-day study with oral Rextoro (n=144). Both trials demonstrated T replacement and with the revised dose-titration algorithm, the Cmax was comparable to other T-replacement therapies.

A second study evaluated the safety of Rextoro in Hypogonadal men in two Phase III clinical trials. Each trial differed in design, dose-titration algorithm and duration as noted above. Trial I evaluated the safety profile of Rextoro for up to 365 days of continuous therapy compared with transdermal T-gel, and Trial II evaluated the safety profile of Rextoro for up to 114 days using the final dose-titration algorithm that results in a lower T exposure. Safety was assessed through adverse event reporting, physical exams, routine clinical laboratory and dihydrotestosterone measurements. No deaths occurred in either trial. These two studies demonstrate that the SEDDS formulation of oral TU utilized in Rextoro has a safety profile consistent with T-gel and is generally well tolerated in men with hypogonadism. Researchers will present results from the two multi-center trials at the 16th International Congress of Endocrinology and The Endocrine Society's 96th Annual Meeting.