This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGThe rate of castration at the end of week 4 (i.e. day 29)
Time frame: 4 weeks
The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide
Time frame: 4 weeks
The duration of castration (i.e Tcast)
Time frame: 4 weeks
LH concentration
Time frame: 4 weeks
FSH concentration
Time frame: 4 weeks
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