Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT01071005
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
Sponsor:
Azidus Brasil
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Versão 03 - Emenda 1 | None | None | View |