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IRCT20200608047702N1 IRCT 2021-12-25 Tabriz University of Medical Sciences The effect of finasteride in the prevention of bladder tumor recurrence The effect of finasteride (compared to placebo) in preventing recurrence in patients with bladder tumor 2021-06-05 anticipated 124 Complete https://irct.ir/trial/48767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 124 envelopes are prepared with 62 active and 62 placebo cards and shuffled. Patients are allocated the next study number (1–124) in sequence after opening the sealed envelopes to either drug or placebo group, Blinding description: The researcher does not know whether the patient being evaluated belongs to the placebo group or the finasteride group. The patients also do not know if they have used a placebo or finasteride. Drugs and placebos are similar in appearance, such as color, shape, and so on. The patient (placebo or treatment groups) receives the encoded drug. 3 bladder cancer. Intervention 1: Intervention group: Finasteride ( Daru Pakhsh CO. Tehran, Iran) receive 5 mg /day and complications and response to treatment are evaluated every three months. Intervention 2: Control group: Receive placebo (in the form of finasteride tablets) (Construction of Faculty of Pharmacy, Tabriz University of Medical Sciences)tablet per day for up to one year. Yes - There is a plan to make this available What will be shared: Part of the data on the outcome of bladder tumors is for sharing. When: Access will be 6 months after the results are printed. To whom: Urologic specialists in coordination with the presenter Conditions: The use of data to improve patients' treatment processes is safe Where to obtain: The person responsible for updating study information: dr Reza Ramezani Email: Dr.ramezanireza70@gmail.com How to obtain: Requesting data and study documents will be done by correspondence with the person responsible for updating the study information Comments:
public alireza farshi
golgasht ave,imam reza hospital
tabriz Iran (Islamic Republic of) 1212121212 +98 41 3337 6923 dr.ramezanireza70@gmail.com Tabriz University of Medical Sciences scientific Reza Ramezani
No 1,saadi alley,azari ave,valiasr jonubi blvd,tabriz
Tabriz Iran (Islamic Republic of) 1212121212 +98 41 2321 0333 Dr.ramezanireza70@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with bladder tumors, which are candidates of fallow up Consent to inclusion the study insensitivity to drug Patient cooperation during the study Age 18 to 70 years 18 years 70 years Both No consent to the inclusion of the study Loss of patient in f/u No regular drug use Patients with underlying disease C67.9 Malignant neoplasm of bladder, unspecified Treatment - Drugs Placebo Intervention group: Finasteride ( Daru Pakhsh CO. Tehran, Iran) receive 5 mg /day and complications and response to treatment are evaluated every three months Control group: Receive placebo (in the form of finasteride tablets) (Construction of Faculty of Pharmacy, Tabriz University of Medical Sciences)tablet per day for up to one year Prevention of recurrence of bladder cancer. Timepoint: before intervention and every 3 months for a period of one year. Method of measurement: cystoscopy pathology report. Tabriz University of Medical Sciences Approved 2021-06-04 ethics committee of tabriz medical university imam reza hospital urology department tabriz West Azarbaijan Iran (Islamic Republic of)