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OpenTrials
Completed

NCT Number: NCT01071005

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

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.

Completed

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Key information

Conditions

Age range

40 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lorelin Depot Bergamo

Drug

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

Lupron Depot - Abbott

Drug

Lupron Depot 3,75 mg, single dose.

Primary outcomes

  1. Decrease of serum levels of luteinizing hormone, Testosterone and FSH

    Time frame: 56 days

Secondary outcomes

  1. Evaluation of safety through the adverse affects investigation

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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