Comparative bioequivalency study (pharmacokinetics-pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic or metastatic prostate cancer Volunteers
Not Applicable
- Conditions
- non-metastatic or metastatic prostate cancer.
- Registration Number
- IRCT20170225032759N3
- Lead Sponsor
- Varian Pharmed Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
• Men between the ages of 50 and 90
• patient with non-metastatic or metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• Without cardiovascular, cerebral, renal and liver problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and MS
• Able and willing to sign informed consent form
Exclusion Criteria
• Sensitivity to drugs, especially GnRH-A
• Previous history of chemotherapy
• Other diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of triptorelin concentration. Timepoint: at the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration. Method of measurement: [D-Trp6]-LHRH.
- Secondary Outcome Measures
Name Time Method Measurement of PSA level. Timepoint: At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration. Method of measurement: PSA tumor marker (ng/ml).;Measurement of serum testosterone. Timepoint: At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration. Method of measurement: RIA.;Measurement of serum FSH. Timepoint: At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration. Method of measurement: RIA.