Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
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.