Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm. Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
QuickShot™ for the delivery of testosterone
QuickShot™ for the delivery of testosterone
Standard of care
Mens Health Boston
Brookline, Massachusetts, United States
The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
The area under the curve from time zero to last quantifiable concentration \[AUC (0-t)\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
The maximum observed plasma concentration \[Cmax\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
The average concentration \[Cavg\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
Number of Patients in the PK Parameter Category
The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE
Time frame: 6 weeks
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