Higher initial dose of oral testosterone undecanoate appears safe, efficacious

A starting dose of 400 mg BID of oral testosterone undecanoate (Kyzatrex) is associated with safety and efficacy, as well as high patient satisfaction, according to results of a retrospective chart review presented at the 2024 Sexual Medicine Society of North American Fall Scientific Meeting in Scottsdale, Arizona.¹

Andrew Y. Sun, MD

In terms of background, the investigators, led by Andrew Y. Sun, MD, of Urology Partners of North Texas in Arlington, explained in their abstract that oral testosterone undecanoate is typically started at 200 mg BID for Kyzatrex, 237 mg BID for Jatenzo, and 225 mg BID for Tlando.

“However, many patients attain greater symptomatic benefit at higher doses,” the authors wrote, noting that they frequently utilize a starting dose of 400 mg BID.

For the study, the investigators evaluated men with hypogonadism who received treatment with oral testosterone undecanoate, 400 mg BID, between August 2023 and April 2024. “Medical records were reviewed for baseline and follow-up levels of serum total testosterone (TT), sex hormone binding globin (SHBG), calculated free testosterone (fT), estradiol, hematocrit (Hct), follicle stimulating hormone (FSH), and luteinizing hormone (LH),” the authors wrote in their abstract. Patient satisfaction was documented in the medical record and prescription refill records were used to measure treatment adherence.

The investigators reported that 27 patients met the inclusion criteria and also had complete data. At a mean follow-up of 6 months, a significant increase in TT was observed, from 263 ng/dL at baseline to 798 ng/dL. In addition, SHBG decreased from 32.4 nmol/L to 17.83 nmol/L, and calculated fT increased from 7.24 ng/dL to 26.74 ng/dL. Estradiol increased from 20.5 pg/mL to 24.7 pg/mL, and hematocrit went from 45.0% to 47.4%.

There were no reports of testicular atrophy, and no patients were started on treatment with aromatase inhibitors. One patient experienced a hematocrit rise of 53.2%, and his dose was reduced to 300 mg BID.

In terms of patient-reported adverse events, 2 patients (7.4%) experienced transient gastrointestinal upset. Nearly all patients (26/27) reported improvement in their symptoms and were continuing the treatment. One patient chose to switch to testosterone cypionate injections.

“Initiating oral TU therapy with Kyzatrex at 400 mg BID is safe and effective in achieving therapeutic serum testosterone levels. The high dose was well-tolerated and resulted in substantial symptom improvement, high patient satisfaction, and adherence. These findings support considering a higher starting dose for hypogonadal men considering oral TU therapy,” the authors wrote in their conclusion.

REFERENCE

1. Vo J, Yoon G, Sun AY. Initiating high-dose oral testosterone undecanoate therapy in hypogonadal men: safety, efficacy, and patient satisfaction. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Abstract 204