Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
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.
|Healthy||Drug: Lorelin Depot Bergamo Drug: Lupron Depot - Abbott||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial of the Pharmacodynamics of Lorelin Depot 3.75Mg (Leuprorelin Acetate) Produced by Laboratório Químico Farmacêutico Bergamo LTDA. Compared to Lupron Depot ® 3.75 Mg Produced by Abbott in Healthy Subjects|
- 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 ]
|Study Start Date:||August 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Lorelin Depot - Bergamo
Drug: Lorelin Depot Bergamo
Lorelin Depot Bergamo, 3,75 mg, single dose.
Active Comparator: comparator
Lupron Depot® - Abbott
Drug: Lupron Depot - Abbott
Lupron Depot 3,75 mg, single dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071005
|Lal Clinica Pesquisa E Desenvolvimento Ltda|
|Valinhos, SP, Brazil, 13270000|