During the trial, hypogonadal men, receive Nebido via intramuscular injection every 12 weeks. The primary endpoint in the pharmacokinetic trial is the assessment of average serum testosterone levels at steady state, measured after the fourth injection.
“I believe the rapid pace at which we were able to enroll patients gives an early indication of the potential market interest in the unique treatment option provided by Nebido,” said Dr Glenn Cooper, chairman, president and CEO of Indevus.
Nebido was recently approved and launched in Europe and will become the first three-month testosterone preparation available in the US if approved. Indevus acquired US rights to Nebido from Schering AG in July 2005.