The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Transdermal testosterone applied daily for 4 weeks
Watson investigational site
Miramar, Florida, United States
Watson investigational site
Omaha, Nebraska, United States
Watson investigational site
San Antonio, Texas, United States
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Time frame: Day 28/29
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