NCT01071005

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: Male
• Age: 40 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lorelin Depot Bergamo	Lorelin Depot Bergamo, 3,75 mg, single dose.
DRUG	Lupron Depot - Abbott	Lupron Depot 3,75 mg, single dose.

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2010-02-18
• Last updated: 2013-02-25

Locations

1 site across 1 country: Brazil