Conditions: Hypogonadism
Keywords: hypogonadism, testosterone, transdermal system
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

Detailed description:
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

Arms:
arm 1: Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Day 16, on Day 22 subjects could be dose-titrated up to dose level C (one 28 cm2 plus one 48 cm2 TMTS), down to dose level A (one 28 cm2 TMTS), or remain at dose level B. Subjects at all dose levels were pooled for primary efficacy analysis on Days 29/30.

Interventions: intervention 1: testosterone matrix transdermal system
Intervention descriptions: intervention 1: None

Protocol document: