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IRCT20170225032759N3 IRCT 2021-04-06 Varian Pharmed Co 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 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 2022-02-26 anticipated 80 Complete https://irct.ir/trial/55332 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on randomized classification blocks. The randomization sequence will be created using the RandBETWEEN in Excel program, Blinding description: People who in this study will be unaware of the type of intervention prescribed to patients participating in the study are: •Patient • Principal Investigator (Physician) The person who is aware of the type of intervention prescribed to patients in this study is the central staff that patients will refer to during the previous coordination, and based on the random allocation list, one of the two interventions will be prescribed for them. Bioequivalence non-metastatic or metastatic prostate cancer. Intervention 1: Intervention group: ِDiphereline 11.25 mg single dose for 3 months. Intervention 2: Intervention group: Variopeptyl 11.25 mg single dose for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Amir mansour Jalali Nadooshan
Tehran, No5, Laleh St, Sattari St
Tehran Iran (Islamic Republic of) 1473896381 +98 21 4448 3009 info@varianpharmed.com Varian Pharmed Co scientific Dr Pouria Adeli
Hezarjerib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 1111111111 +98 31 3792 3071 drpouriaadeli.ir@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) • 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 50 years 90 years Male • Sensitivity to drugs, especially GnRH-A • Previous history of chemotherapy • Other diseases Treatment - Drugs Treatment - Drugs Intervention group: ِDiphereline 11.25 mg single dose for 3 months Intervention group: Variopeptyl 11.25 mg single dose for 3 months 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. 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. Varian Pharmed Co Approved 2021-03-09 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)