Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000, Brazil
NCT Number: NCT01071005
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.
Looking for future studies?
Notify Me40 year–45 year
Male
Interventional
Phase 1
Valinhos, São Paulo, 13270000, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lorelin Depot Bergamo, 3,75 mg, single dose.
Lupron Depot 3,75 mg, single dose.
Time frame: 56 days
Time frame: 56 days
Azidus Brasil
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06861829
Healthy
Biberach, Germany
View Trial DetailsNCT06429137
Healthy
Biberach, Germany
View Trial DetailsNCT01520792
Healthy
Clermont-Ferrand, France
View Trial DetailsNCT07542886
Healthy
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial Details