SUN-133 - A Multivariable Dose-Selection Predictor to Optimize JATENZO® Dose Titration in Hypogonadal Men

Over 2.4 million US men have hypogonadism, defined as serum testosterone (T) levels < 300 ng/dL with symptoms of T deficiency. Hypogonadism associated negative effects include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral testosterone therapies (TTh) provide a route of administration that may better suit some patients’ needs. The first FDA-approved oral, titratable testosterone undecanoate (TU, JATENZO®) is available in 3 strengths and 5 twice daily (BID) doses (158, 198, 237, 316, and 396 mg). While the ability to titrate is a clinical advantage, determining the optimal dose for each patient can be challenging and for some patients, may require multiple follow-up visits and coordination. To streamline and support individualized dosing decisions, the objective of this research is to develop an evidence-based dose predictor designed to identify a predicted TU dose using patient-specific factors.

Data from the phase 3 inTUNE trial were used to identify patient and treatment factors associated with changes in T following adjustments in oral TU doses. Factors evaluated include age, BMI, and change in oral TU dose. Single-variable regression was performed to identify significant predicting factors for change in T, which were then incorporated into a multivariable linear regression model. The results from the multivariable regression model were used to develop the JATENZO® Dose-Selection Predictor, which calculates the recommended TU dose among the available titratable strengths (158, 198, 237, 316, and 396 mg BID).

From the single variable regression, BMI, age, and change in dose were significant predictors for change in T (p < 0.1). Higher BMI and older age were associated with the need for higher TU doses to achieve comparable T increases as those with lower BMI and younger age. An illustrative example of a patient with T=300 ng/dL on 237 mg BID, age 45, BMI 30 kg/m², and a target serum T of 470 ng/dL generated a recommended dose increase to 316 mg BID.

The multivariable dose-selection predictor provides clinicians with a practical and evidence-based tool to support individualized TU dosing. This approach has the potential to reduce time to therapeutic range, improve safety and tolerability, enhance confidence in dose selection, and minimize frequent clinic visits. Future work will incorporate ongoing, additional clinical trial data as well as real-world datasets to further improve precision and clinical utility.

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