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

NCT01071005 | Completed Phase 1

• 2 other identifiers: LEUBER0409Versão 03 - Emenda 1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Decrease serum levels of luteinizing hormone, FSH and Testosterone

Outcome Measures

Primary Outcomes (1)

• Decrease of serum levels of luteinizing hormone, Testosterone and FSH

  56 days

Secondary Outcomes (1)

• Evaluation of safety through the adverse affects investigation

  56 days

Study Arms (2)

Test

EXPERIMENTAL

Lorelin Depot - Bergamo

Drug: Lorelin Depot Bergamo

comparator

ACTIVE COMPARATOR

Lupron Depot® - Abbott

Drug: Lupron Depot - Abbott

Interventions

Lorelin Depot Bergamo DRUG

Lorelin Depot Bergamo, 3,75 mg, single dose.

Test

Lupron Depot - Abbott DRUG

Lupron Depot 3,75 mg, single dose.

comparator

Eligibility Criteria

• Age: 40 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: February 18, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

BR (1)