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* Overall, oral TU achieved similar T levels across BMI subgroups with higher BMI patients utilizing higher doses. Men may likely require different T doses based on factors such as BMI to achieve effective levels.
Titratable Oral Testosterone Undecanoate Achieved Similar Testosterone Levels Across BMI Subgroups
m.khera, Baylor College of Medicine, Houston, TX, USA Baylor College of
rhea.daugherty, Tolmar, Inc., Buffalo Grove, IL, USA
debbie.boldt, Tolmar, Inc., Buffalo Grove, IL, USA
stuart.atkinson, Tolmar, Inc., Buffalo Grove, IL, USA
Introduction
>2.4 million US men have hypogonadism1, defined as serum testosterone (T)<300 ng/dL2. Negative effects associated with hypogonadism include development of metabolic syndrome3, increased risk of coronary artery disease4, and decreased libido5. Oral T replacement therapies provide a route of administration that may be more appropriate for some patients’ needs. As not all patients are the same and do not metabolize drugs the same way, the ability to titrate oral T replacement therapies may be beneficial. We present analyses from a phase 3 study of testosterone undecanoate (TU) to explore the relationship between body mass index (BMI) and T levels achieved.
Methods
A phase 3, randomized, active controlled, open-label study was conducted to assess the safety and efficacy of oral TU in 222 hypogonadal men. The initial oral TU dose was 237mgTU BID. Titration adjustments were made on Day 35 and 70 based on the 24-hour average T concentration on day 21 and 56. BMI subgroups were <25, 25-<30, 30-<35, and ≥35 kg/m2.
Results
Mean T at 4 hours post-dose by BMI subgroups are shown in Figure 1. Mean TU doses on day 105 were 237, 312, 326 and 353 mg for <25, 25-<30, 30-<35, and ≥35 kg/m2 BMI subgroups, respectively (Figure 1). Percentage of patients who required 0, 1, or 2 titrations were 25%, 34%, and 41%, respectively.
Conclusions
Overall, oral TU achieved similar T levels across BMI subgroups with higher BMI patients utilizing higher doses. Men may likely require different T doses based on factors such as BMI to achieve effective levels. Therefore, an oral T replacement therapy that allows for dose titration would likely be preferable to a fixed dose.
Figure 1: Mean Serum Testosterone and Dose at Hour 4 From Baseline to Day 105 by BMI (kg/m) Subgroups (N=155)
Titratable Oral Testosterone Undecanoate Achieved Similar Testosterone Levels Across BMI Subgroups
m.khera, Baylor College of Medicine, Houston, TX, USA Baylor College of
rhea.daugherty, Tolmar, Inc., Buffalo Grove, IL, USA
debbie.boldt, Tolmar, Inc., Buffalo Grove, IL, USA
stuart.atkinson, Tolmar, Inc., Buffalo Grove, IL, USA
Introduction
>2.4 million US men have hypogonadism1, defined as serum testosterone (T)<300 ng/dL2. Negative effects associated with hypogonadism include development of metabolic syndrome3, increased risk of coronary artery disease4, and decreased libido5. Oral T replacement therapies provide a route of administration that may be more appropriate for some patients’ needs. As not all patients are the same and do not metabolize drugs the same way, the ability to titrate oral T replacement therapies may be beneficial. We present analyses from a phase 3 study of testosterone undecanoate (TU) to explore the relationship between body mass index (BMI) and T levels achieved.
Methods
A phase 3, randomized, active controlled, open-label study was conducted to assess the safety and efficacy of oral TU in 222 hypogonadal men. The initial oral TU dose was 237mgTU BID. Titration adjustments were made on Day 35 and 70 based on the 24-hour average T concentration on day 21 and 56. BMI subgroups were <25, 25-<30, 30-<35, and ≥35 kg/m2.
Results
Mean T at 4 hours post-dose by BMI subgroups are shown in Figure 1. Mean TU doses on day 105 were 237, 312, 326 and 353 mg for <25, 25-<30, 30-<35, and ≥35 kg/m2 BMI subgroups, respectively (Figure 1). Percentage of patients who required 0, 1, or 2 titrations were 25%, 34%, and 41%, respectively.
Conclusions
Overall, oral TU achieved similar T levels across BMI subgroups with higher BMI patients utilizing higher doses. Men may likely require different T doses based on factors such as BMI to achieve effective levels. Therefore, an oral T replacement therapy that allows for dose titration would likely be preferable to a fixed dose.
Figure 1: Mean Serum Testosterone and Dose at Hour 4 From Baseline to Day 105 by BMI (kg/m) Subgroups (N=155)
