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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
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.
Details
| Lead sponsor | Azidus Brasil |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 58 |
| Start date | 2010-08 |
| Completion | 2011-01 |
Conditions
- Healthy
Interventions
- Lorelin Depot Bergamo
- Lupron Depot - Abbott
Primary outcomes
- Decrease of serum levels of luteinizing hormone, Testosterone and FSH — 56 days
Countries
Brazil