The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance. Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Lorelin Depot Bergamo, 3,75 mg, single dose.
Lupron Depot 3,75 mg, single dose.
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
Decrease of serum levels of luteinizing hormone, Testosterone and FSH
Time frame: 56 days
Evaluation of safety through the adverse affects investigation
Time frame: 56 days
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