Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT01071005
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2009-06-04', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease of serum levels of luteinizing hormone, Testosterone and FSH', 'timeFrame': '56 days'}], 'secondaryOutcomes': [{'measure': 'Evaluation of safety through the adverse affects investigation', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Decrease serum levels of luteinizing hormone, FSH and Testosterone'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondarily 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Accept the Informed Consent.\n2. Subjects of research males aged 40 to 45 years;\n3. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;\n4. Be considered healthy, from the analysis of the clinical history and medical examination;\n5. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.\n\nExclusion Criteria:\n\n1. Have donated or lost 450 mL or more of blood in the three months preceding the study;\n2. Have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;\n3. 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;\n4. Have been hospitalized for any reason, up to 8 weeks before the study;\n5. Provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;\n6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;\n7. Amendments pressure of any etiology requiring pharmacological treatment;\n8. Present history of myocardial infarction, angina and / or heart failure.'}, 'identificationModule': {'nctId': 'NCT01071005', 'briefTitle': 'Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LEUBER0409'}, 'secondaryIdInfos': [{'id': 'Versão 03 - Emenda 1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Lorelin Depot - Bergamo', 'interventionNames': ['Drug: Lorelin Depot Bergamo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'comparator', 'description': 'Lupron Depot® - Abbott', 'interventionNames': ['Drug: Lupron Depot - Abbott']}], 'interventions': [{'name': 'Lorelin Depot Bergamo', 'type': 'DRUG', 'description': 'Lorelin Depot Bergamo, 3,75 mg, single dose.', 'armGroupLabels': ['Test']}, {'name': 'Lupron Depot - Abbott', 'type': 'DRUG', 'description': 'Lupron Depot 3,75 mg, single dose.', 'armGroupLabels': ['comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13270000', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Lal Clinica Pesquisa E Desenvolvimento Ltda', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alexandre Frederico', 'oldOrganization': 'LAL Clinica Pesquisa e Desenvolvimento Ltda'}}}}