The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Serum T Concentration at Steady State
Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.
Time frame: pre-dose on Days 1, 3, 5, 6, and 7
Serum T Concentration at Steady-State
Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.
Time frame: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
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