Dose titration is not required in most patients receiving oral softgel testosterone

A recent assessment of the oral softgel formulation of testosterone undecanoate (TU, Jatenzo) indicates that dose titration is not required in most patients receiving the treatment.¹

The finding was part of a study presented at the 2021 Sexual Medicine Society of North America Fall Scientific Meeting by Robert E. Dudley, PhD, and co-authors.

For the study, the investigators performed pharmacokinetic (PK) simulations using a robust population PK model that was developed for testosterone in 474 men with hypogonadism who were treated with oral TU in previous PK studies. Average testosterone concentrations (Cavg) were derived from multiple serial blood samples collected over 24 hours for oral TU doses of 237 mg, 316 mg, and 396 mg twice daily. The investigators calculated the percent of subjects with T levels within the eugonadal range (serum Cavg between 304 ng/dL and 1030 ng/dL) at each of the TU dose levels. To assess the frequency of real-world dose titration, prescription data were accessed from the Symphony PatientSource Patient Transactional Dataset.

The investigators found that the percentage of subjects with steady state Cavg within the eugonadal range for 237 mg, 316 mg, and 396 mg twice daily were 61%, 74%, and 74%, respectively. These percentages corresponded to mean serum testosterone levels of 398 ng/dL, 560 ng/dL, and 728 ng/dL, respectively. In addition, wrote the authors, “Early assessment of real-world prescribing data for JATENZO indicated 35% of patients underwent dose titration by month 5.”

According to the investigators, their findings were consistent with initial real-world experience with oral TU indicating that dose titration is not required in most patients.

“However,” wrote the authors, “because the desired outcome of TRT therapy focuses on both T Cavg and symptomatic response, this oral TU formulation enables necessary dose adjustment when needed.”

Reference

1. Dudley R, Newmark J, Stark S, Pheng L, Beliveau M, Longstreth J. Real-world experience with first FDA-approved oral testosterone undecanoate formulation. Paper presented at 2021 Sexual Medicine Society of North America Fall Scientific Meeting; October 21-24, 2021; Scottsdale, Arizona. Abstract 028.