Search for predictors of nontherapeutic INR results with warfarin therapy.

Background: The effectiveness and safety of warfarin require maintaining an international normalized ratio (INR) within the therapeutic range.

Objective: To identify predictors of nontherapeutic INR results in patients receiving warfarin.

Methods: A retrospective study was conducted using 350 ambulatory care patients from a broad geographic region, all receiving long-term warfarin therapy and followed in a tertiary-care cardiology clinic.

Transdermal testosterone gel (Cellegy).

Cellegy is developing a drug delivery system designed to facilitate the transdermal and topical delivery of testosterone for the potential treatment of male hypogonadism (as Tostrex) and decreased sexual energy in post-menopausal women (asTostrelle) [218118], [314726], [351823]. Following phase III dinical trials of Tostrex for male hypogonadism, initiated in March 2000 [361133], an NDA submission for male hypogonadism was filed in June 2002, after a pre-NDA meeting with the FDA late in 2001 [453374]. By March 2002, phase II/III clinical studies in postmenopausal women were underway in the US [444857].