The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
GSK Investigational Site
Torrance, California, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Durham, North Carolina, United States
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
Time frame: days 1 and 28
Testosterone concentration .
Time frame: on days 1 and 28
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Time frame: days 1 and 28.
Anabolic & androgenic Pharmacodynamic biomarkers
Time frame: pre- and post-dose
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GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Seattle, Washington, United States