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Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

2014-08-27 03:15:49 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Lorelin Depot Bergamo, Lupron Depot - Abbott

Location

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos
SP
Brazil
13270000

Status

Not yet recruiting

Source

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:49-0400

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