Comparative Study Shows Striant(R) Consistently Achieves Normal Testosterone Levels
May 04 2004 - 9:01AM
PR Newswire (US)
Comparative Study Shows Striant(R) Consistently Achieves Normal
Testosterone Levels Researchers Conclude Latest FDA-Approved
Hypogonadism Therapy is a Valuable Treatment Option for
Testosterone-Deficient Men LIVINGSTON, N.J., May 4
/PRNewswire-FirstCall/ -- Results of an international multicenter
study comparing the steady-state pharmacokinetics and tolerability
of Striant(R) (testosterone buccal system) (CIII) with a
testosterone containing skin patch show that use of Striant
produces physiologic (normal) testosterone levels in hypogonadal
men and achieves testosterone concentrations within the normal
range. Hypogonadism, a condition associated with a deficiency or
absence of endogenous testosterone, affects nearly five million
American men. Study results are published in this month's issue of
the Journal of Clinical Endocrinology and Metabolism. In the
open-label, parallel arm study, 66 patients with a morning serum
testosterone less than 6.94 nmol/liter were randomized into two
groups. Of the 57 patients who completed the study protocol, 29
patients were treated with Striant (30 mg) twice daily for seven
days, while 28 patients in the other group applied a transdermal
testosterone patch daily for seven days. Serum testosterone and
dihydrotestosterone (DHT) concentrations were measured periodically
over six days and then serially over the last 24 hours of the
study. The average serum testosterone concentration over 24 hours
showed a mean of 18.74 nmol/liter in the Striant group, and 12.15
nmol/liter in the transdermal patch group (P