Healthy
Conditions
Keywords
Decrease serum levels of luteinizing hormone, FSH and Testosterone
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.
Interventions
DRUGLorelin Depot Bergamo
Lorelin Depot Bergamo, 3,75 mg, single dose.
DRUGLupron Depot - Abbott
Lupron Depot 3,75 mg, single dose.
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Accept the Informed Consent. 2. Subjects of research males aged 40 to 45 years; 3. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30; 4. Be considered healthy, from the analysis of the clinical history and medical examination; 5. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.
Exclusion criteria
1. Have donated or lost 450 mL or more of blood in the three months preceding the study; 2. Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study; 3. Have made regular use of medication in the last 4 weeks prior to the start of the study or have made use of any medication a week before the study began; 4. Have been hospitalized for any reason, up to 8 weeks before the study; 5. Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization; 6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric; 7. Amendments pressure of any etiology requiring pharmacological treatment; 8. Present history of myocardial infarction, angina and / or heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of serum levels of luteinizing hormone, Testosterone and FSH | 56 days |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety through the adverse affects investigation | 56 days |
Countries
Brazil
Outcome results
None listed