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

February 22, 2013 updated by: Azidus Brasil

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Valinhos, SP, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Lorelin Depot - Bergamo
Drug: Lorelin Depot Bergamo
Lorelin Depot Bergamo, 3,75 mg, single dose.
Active Comparator: comparator
Lupron Depot® - Abbott
Drug: Lupron Depot - Abbott
Lupron Depot 3,75 mg, single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of serum levels of luteinizing hormone, Testosterone and FSH
Time Frame: 56 days
56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety through the adverse affects investigation
Time Frame: 56 days
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEUBER0409
  • Versão 03 - Emenda 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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