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

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01071005
First received: June 4, 2009
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Lorelin Depot Bergamo
Drug: Lupron Depot - Abbott
Phase 1

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

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Decrease of serum levels of luteinizing hormone, Testosterone and FSH [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of safety through the adverse affects investigation [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071005

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01071005     History of Changes
Other Study ID Numbers: LEUBER0409, Versão 03 - Emenda 1
Study First Received: June 4, 2009
Last Updated: February 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Decrease serum levels of luteinizing hormone, FSH and Testosterone

Additional relevant MeSH terms:
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014