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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Azidus Brasil
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Decrease of serum levels of luteinizing hormone, Testosterone and FSH
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Accept the Informed Consent.
- •Subjects of research males aged 40 to 45 years;
- •Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;
- •Be considered healthy, from the analysis of the clinical history and medical examination;
- •Laboratory tests with results outside the values considered normal, but not considered clinically relevant.
Exclusion Criteria
- •Have donated or lost 450 mL or more of blood in the three months preceding the study;
- •Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;
- •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;
- •Have been hospitalized for any reason, up to 8 weeks before the study;
- •Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;
- •Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
- •Amendments pressure of any etiology requiring pharmacological treatment;
- •Present history of myocardial infarction, angina and / or heart failure.
Arms & Interventions
Test
Lorelin Depot - Bergamo
Intervention: Lorelin Depot Bergamo (Drug)
comparator
Lupron Depot® - Abbott
Intervention: Lupron Depot - Abbott (Drug)
Outcomes
Primary Outcomes
Decrease of serum levels of luteinizing hormone, Testosterone and FSH
Time Frame: 56 days
Secondary Outcomes
- Evaluation of safety through the adverse affects investigation(56 days)