Nelson Vergel
Founder, ExcelMale.com
We finally have a study that looked at this common question.
Effect of Weight on Serum Testosterone Levels with Subcutaneous Testosterone Enanthate in Men with Testosterone Deficiency
Introduction
Obesity is a common issue among men and is often associated with low testosterone (T) levels. This association complicates the management of testosterone deficiency (hypogonadism) in overweight and obese individuals. It is known that men with a higher body mass index (BMI) need higher doses of transdermal testosterone therapy (TTh), like T 2% gel, to get their T levels back to normal. However, not much is known about how body weight affects the pharmacokinetics and dosing of subcutaneous testosterone enanthate (TE) in men who are T deficient. A recent post hoc analysis of a phase 3 trial sheds light on the relationship between body weight and serum T levels achieved with SC TE therapy.
Study Background
A post hoc analysis of data from a 52-week, open-label, single-arm, dose-blinded phase 3 trial (NCT02159469) was used to look into the safety and effectiveness of giving men with low testosterone SC TE once a week. The trial enrolled 150 men, with a primary endpoint of achieving an average serum T concentration (Cavg0-168h) between 300 to 1,100 ng/dL at week 12. This study aimed to assess how different body weights influenced the serum T levels attained with varying doses of SC TE.
Methods
Participants in the study self-administered a starting dose of 75 mg SC TE weekly during the initial titration phase. Subsequently, blinded dose adjustments in increments of 25 mg were made at predefined intervals beyond the sixth dose, based on serum T levels. As a post hoc analysis, a linear regression model was used to look at the effect on mean minimum T concentration (Cmin) and Cavg0-168h at week 12. Body weight and dose were used as independent variables.
Results
A total of 137 men were included in the post hoc analysis. The participants were divided into three dose groups: 50 mg (n=25), 75 mg (n=93), and 100 mg (n=19). The average weights in these groups were 84.4 kg, 102.2 kg, and 112.0 kg, respectively, with a range of 49.9–146.5 kg. The analysis revealed an inverse relationship between body weight and serum T levels. Specifically, the dose-normalized T Cmin and Cavg0-168h decreased as the dose increased:
Conclusion
This analysis highlights an inverse correlation between body weight and T exposure in men undergoing SC TE therapy. Men with higher body weights required higher doses of SC TE to achieve physiological T levels, compared to those with lower body weights. The findings underscore the importance of individualized dosing based on body weight to optimize testosterone therapy outcomes. The study provides valuable insights for clinicians in tailoring SC TE therapy, ensuring effective management of testosterone deficiency in men across different weight categories.
These results add to the growing body of knowledge on how weight impacts the pharmacokinetics of testosterone therapy and suggest that SC TE offers a flexible and effective option for achieving target testosterone levels in men with varying body weights.
Effect of Weight on Serum Testosterone Levels with Subcutaneous Testosterone Enanthate in Men with Testosterone Deficiency
Introduction
Obesity is a common issue among men and is often associated with low testosterone (T) levels. This association complicates the management of testosterone deficiency (hypogonadism) in overweight and obese individuals. It is known that men with a higher body mass index (BMI) need higher doses of transdermal testosterone therapy (TTh), like T 2% gel, to get their T levels back to normal. However, not much is known about how body weight affects the pharmacokinetics and dosing of subcutaneous testosterone enanthate (TE) in men who are T deficient. A recent post hoc analysis of a phase 3 trial sheds light on the relationship between body weight and serum T levels achieved with SC TE therapy.
Study Background
A post hoc analysis of data from a 52-week, open-label, single-arm, dose-blinded phase 3 trial (NCT02159469) was used to look into the safety and effectiveness of giving men with low testosterone SC TE once a week. The trial enrolled 150 men, with a primary endpoint of achieving an average serum T concentration (Cavg0-168h) between 300 to 1,100 ng/dL at week 12. This study aimed to assess how different body weights influenced the serum T levels attained with varying doses of SC TE.
Methods
Participants in the study self-administered a starting dose of 75 mg SC TE weekly during the initial titration phase. Subsequently, blinded dose adjustments in increments of 25 mg were made at predefined intervals beyond the sixth dose, based on serum T levels. As a post hoc analysis, a linear regression model was used to look at the effect on mean minimum T concentration (Cmin) and Cavg0-168h at week 12. Body weight and dose were used as independent variables.
Results
A total of 137 men were included in the post hoc analysis. The participants were divided into three dose groups: 50 mg (n=25), 75 mg (n=93), and 100 mg (n=19). The average weights in these groups were 84.4 kg, 102.2 kg, and 112.0 kg, respectively, with a range of 49.9–146.5 kg. The analysis revealed an inverse relationship between body weight and serum T levels. Specifically, the dose-normalized T Cmin and Cavg0-168h decreased as the dose increased:
- 50 mg group: Dose-normalized T Cmin was 9.2 ng/dL, and Cavg0-168h was 12.0 ng/dL per 1 mg of SC TE.
- 75 mg group: Dose-normalized T Cmin was 5.7 ng/dL, and Cavg0-168h was 7.2 ng/dL per 1 mg of SC TE.
- 100 mg group: Dose-normalized T Cmin was 4.3 ng/dL, and Cavg0-168h was 5.7 ng/dL per 1 mg of SC TE.
Conclusion
This analysis highlights an inverse correlation between body weight and T exposure in men undergoing SC TE therapy. Men with higher body weights required higher doses of SC TE to achieve physiological T levels, compared to those with lower body weights. The findings underscore the importance of individualized dosing based on body weight to optimize testosterone therapy outcomes. The study provides valuable insights for clinicians in tailoring SC TE therapy, ensuring effective management of testosterone deficiency in men across different weight categories.
These results add to the growing body of knowledge on how weight impacts the pharmacokinetics of testosterone therapy and suggest that SC TE offers a flexible and effective option for achieving target testosterone levels in men with varying body weights.
SAT-037 Effect of Weight on Serum Testosterone with Subcutaneous Testosterone Enanthate in Men with Testosterone Deficiency
Abstract. BACKGROUND: In men, obesity is often associated with low testosterone (T) levels, but information is limited as to how body weight affects the pharmac
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