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
Completed
- 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
- Secondary Outcome Measures
Name Time Method