Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
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|ClinicalTrials.gov Identifier: NCT01071005|
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Lorelin Depot Bergamo Drug: Lupron Depot - Abbott||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||January 2011|
Lorelin Depot - Bergamo
Drug: Lorelin Depot Bergamo
Lorelin Depot Bergamo, 3,75 mg, single dose.
Active Comparator: comparator
Lupron Depot® - Abbott
Drug: Lupron Depot - Abbott
Lupron Depot 3,75 mg, single dose.
- Decrease of serum levels of luteinizing hormone, Testosterone and FSH [ Time Frame: 56 days ]
- Evaluation of safety through the adverse affects investigation [ Time Frame: 56 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071005
|Lal Clinica Pesquisa E Desenvolvimento Ltda|
|Valinhos, SP, Brazil, 13270000|