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IRCT2016090410178N10 IRCT 2016-10-29 Shahid Beheshti University of Medical Sciences Bioequivalence study of two Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer Comparative bioequivalence study of two sustained release Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer based on biologic response (serum PSA and Testosterone levels) 2016-10-22 anticipated 50 Complete https://irct.ir/trial/10632 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using individualized simple randomization method by Rnd function of Excel software, Blinding description: Patients who are candidate to receive triptorelin, based on physician's decision, will be referred to researcher and using pre-designed randomization table will be allocated in study arms. Data will be send to data analyzer using codes and decoding will be done after completion of data analysis. 2-3 Metastatic prostate cancer. Intervention 1: Diphereline (Triptorelin acetate manufactured by IPSEN, France) 3.75mg IM every 28 days for 3 doses. Intervention 2: Decareline (Triptorelin acetate manufactured by Ronak Darou, Iran) 3.75mg IM every 28 days for 3 doses. Yes - There is a plan to make this available What will be shared: Data related to primary objectives When: Starting 6 months after publication To whom: People working in academic institutions; pharmaceutical companies Conditions: With official letter Where to obtain: Mohammad Sistanizad How to obtain: Data are available 6 months after publication of results Comments:
public Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1991953381 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1991953381 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Metastatic prostate cancer Signing written consent form 18 years no limit Male Hypothalamic pituitary gonadal axis dysfunction Malignancy other than prostate cancer Treatment with other Gonadotropin Releasing Hormone (GnRH) analogues, hormones, radiotherapy or chemotherapy during recent three months Allergy to GnRH, GnRH analogues or to any component of medications C61 Malignant neoplasm of prostate Treatment - Drugs Treatment - Drugs Diphereline (Triptorelin acetate manufactured by IPSEN, France) 3.75mg IM every 28 days for 3 doses Decareline (Triptorelin acetate manufactured by Ronak Darou, Iran) 3.75mg IM every 28 days for 3 doses Prostate Specific Antigen (PSA) serum level. Timepoint: Before injection of each dose of medication for 3 months. Method of measurement: Biomerieux Vidas kits. Testostrone serum level. Timepoint: Before injection of each dose of medication for 3 months. Method of measurement: Biomerieux Vidas kits. Ronak Pharm Shahid Beheshti University of Medical Sciences Ronak Pharm Approved 2016-07-20 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak Street, Shahid Chamran High Way Tehran Tehran Iran (Islamic Republic of)