(052) Titratable Oral Testosterone Undecanoate Achieved Testosterone Level Increase of ≥500 NG/DL Across BMI Subgroups

Abstract Introduction >2.4 million US men have hypogonadism, defined as a serum testosterone (T) level <300 ng/dL with symptoms of T deficiency. Negative effects associated with hypogonadism 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 be more appropriate for some patients’ needs. We present secondary analyses of T data from the phase 3 inTUNE study of the first oral titratable testosterone undecanoate (TU) approved in the US which is available in 3 strengths and 5 BID doses (158, 198, 237, 316, and 396 mg). Objective The objective of the study is to demonstrate that oral TU doses effectively achieve and maintain normal mean serum T concentration in patients across all BMI groups. Methods A phase 3, randomized, active controlled, open-label study was conducted to assess the safety and efficacy of the first US oral TU in 166 hypogonadal men. Men ≥18 to ≤75 years with morning serum T ≤300 ng/dL twice in one week were eligible. The initial oral TU dose was 237 mg TU twice a day. Titration opportunities were on Days 35 and 70 based on the 24-hour average T concentration on Days 21 and 56. 4 hours post-dose serum T measurements were analyzed before and after each titration adjustment (Days 21, 56 and 105, respectively). BMI subgroups were <25, 25-<30, 30-<35, and ≥35 kg/m2. Results 154 men had serum T data. Overall, 99% of patients achieved serum T ≥300 ng/dL on Day 105 after 2 titration opportunities. Patients had a mean serum T increase of 578 ng/dL from screening to Day 105, achieving a mean serum T of 773 ng/dL. Patients with BMI <25, 25 to <30, 30 to <35, and ≥35 kg/m2 had mean serum T increases of 870, 601, 534, and 561 ng/dL, respectively, from screening to Day 105. Conclusions Overall, almost all patients achieved serum T ≥300 ng/dL with 2 titration opportunities. Oral TU achieved similar T levels increase of ~530-600 ng/dL across BMI ≥25 kg/m2 subgroups. Men may likely require different T doses based on factors such as BMI to achieve effective levels. Therefore, an oral T therapy that allows for dose titration may be a welcome option for some patients and clinicians. Future studies and investigations should evaluate patient factors that may impact the magnitude of T increases from changes in TU doses as this would allow for more individualized titrations and guide clinicians to determine more optimal doses based on these patient factors. Disclosure Yes, this is sponsored by industry/sponsor: Tolmar, Inc. Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Tolmar, Inc.

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