Short-term pharmacokinetic comparison of a novel testosterone buccal system and a testosterone gel in testosterone deficient men

SUMMARY

Objective: The primary objective of the study was to compare the percentage of men with mean serum total T (Cave(0–24)) within normal range during the 24-h pharmacokinetic (PK) sampling period on Days 14 and 15.

Methods: Treatment with a new testosterone (T) buccal system, (Striant), 30mg twice daily was compared to a transdermal gel delivery system, (T-gel) [AndroGel 5 g containing 1% (50 mg) T] daily for 14days in T-deficient men. Safety parameters included laboratory assessments and collection of adverse events. Patients were otherwise healthy T-deficient men with total T < 8.7 nmol/L (< 2.5 ng/mL).

* Striant is a registered trademark of Columbia Laboratories, Inc.

† AndroGel is a registered trademark of Solvay Pharmaceuticals, Inc., Marietta, GA

Results: Twenty-six of the 28 patients enrolled completed the 24-h PK assessment. Of the evaluable patients, 92.3% of T buccal system and 83.3% of T-gel patients had Cave(0–24) within the normal range of 10.4-36.4 nmol/L (3.0–10.5 ng/mL). Mean total T values were not different in the T buccal system group (Cave(0–24) 16.7 ± 4.7 nmol/L; 4.8 ± 1.4 ng/mL) compared to the T-gel group (Cave(0–24) 15.9 ± 4.8 nmol/L; 4.6 ± 1.4 ng/mL). All T values returned to baseline levels after the study drug was stopped. Serum LH and FSH levels decreased, and E2 increased as expected following T administration. Differences in DHT concentrations between treatment groups were significant (p = 0.012) with mean DHT levels on Day 14 of 1.9 ± 1.4 nmol/L (0.55 ± 0.42 ng/mL) for the T buccal system and 3.2 ± 1.3 nmol/L (0.93 ± 0.38ng/mL) for T-gel, which was greater than the upper level of normal (2.9 nmol/L; 0.85 ng/mL). Statistically significant differences were seen in the mean T/DHT ratio on Days 14

Key Words::

• AndroGel®
• Buccal mucoadhesive
• hormone replacement therapy
• Hypogonadism
• pharmacokinetics
• Striant®
• Testosterone

Notes

* Striant is a registered trademark of Columbia Laboratories, Inc.

† AndroGel is a registered trademark of Solvay Pharmaceuticals, Inc., Marietta, GA