To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
5 grams administered using an application Site Rotation
5 grams administered using an a combination of Application sites
Maximum Plasma Concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Time frame: Up to 24 days
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time frame: Up to 24 days
Time of Cmax (Tmax)
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Time frame: Up to 24 days
Average Plasma Concentration observed (Cav)
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Time frame: Up to 24 days
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Time frame: 24 days
Adverse events
Time frame: 24 days
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