Clinical trial NCT01071005: Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Decrease serum levels of luteinizing hormone, FSH and Testosterone
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 58
Sex: MALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Decrease of serum levels of luteinizing hormone, Testosterone and FSH
timeFrame: 56 days
Secondary outcomes:
measure: Evaluation of safety through the adverse affects investigation
timeFrame: 56 days
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: SP
Study officials:
References: