- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071005
Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
SP
-
Valinhos, SP, Brazil, 13270000
- LAL Clínica Pesquisa e Desenvolvimento Ltda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
|
Lorelin Depot Bergamo, 3,75 mg, single dose.
|
Active Comparator: comparator
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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