Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071005
• Other study ID #: LEUBER0409
• Secondary ID: Versão 03 - Emen
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2009
• Last updated: February 22, 2013
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2013
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lorelin Depot Bergamo
Lorelin Depot Bergamo, 3,75 mg, single dose.
• Lupron Depot - Abbott
Lupron Depot 3,75 mg, single dose.

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of serum levels of luteinizing hormone, Testosterone and FSH		56 days	No
Secondary	Evaluation of safety through the adverse affects investigation		56 days	Yes