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| ID | Type | Description | Link |
|---|---|---|---|
| Versão 03 - Emenda 1 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Lorelin Depot - Bergamo |
|
| comparator | Active Comparator | Lupron Depot® - Abbott |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorelin Depot Bergamo | Drug | Lorelin Depot Bergamo, 3,75 mg, single dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of serum levels of luteinizing hormone, Testosterone and FSH | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety through the adverse affects investigation | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| Lupron Depot - Abbott |
| Drug |
Lupron Depot 3,75 mg, single dose. |
|