The Efficacy and side effects of different doses of finastride/ dutastride accompanying with tamsulosin for Benign prostate hyperplasia in Iranian men

1- the comparison of QMAX(maximal flow rate) ,IPSS SCORE( international prostate symptom score) ,SDI SCORE(sexual desire inventory),IIEF15(international index of erectile function) before, 3 and 6 months after treatment in each group and between five groups in this study

randomized ,parallel group trial with blinded outcome assessment .Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site

this study is performed by urology research center in shahid beheshti university of medical sciences.This study include 5 groups .group one is considered as a control group .The finastride 5mg and 3mg , dutastride 0.5mg and 0.25mg and placebo tablets are identical in appearance and prepared by tansnim company. QMAX , IPSS score , IIEF15 score, SDI score are assessed before , 3 and six months after treatment . the complication of drug was assessed in each group .investigator, care provider, patients, data analyzer , outcome assessor were all blinded .

inclusion criteria :prostate size larger than 30 cc, moderate to sever IPSS score . exclusion criteria: PSA more than 4 ng/dl., history of bladder or prostate cancer, history of prostate surgery, history of urethral stricture

group one take tamsulosin 0.4mg once daily and placebo ,group 2 take tamsulosin 0.4mg daily and finasteride 5mg once daily , group 3 take one capsule of tamsulosin 0.4mg and finasteride 3mg once daily , group 4 take one capsule of tamsulosin 0.4mg and dutastride 0.25mg once daily , group 5 take one capsule of tamsulosin 0.4mg and dutastride 0.5mg once daily .

QMax, IPSS SCORE .IIEF15 SCORE . SDI SCORE

simple randomization method will be used. Five labels of treatment groups will be inserted in an excel file orderly and in the corresponding column, random numbers will be produced. By sorting the random numbers, the order of labels will randomly change. This randomized file will be used for the samples and cases who enrolled into our study and they will be grouped based on labels in the file.

تاThis is a multicenter, randomized , double blind, parallel group study.the Patients are randomised to 5 groups (discussed previously). Tamsulosin 0.4 mg is given to all participants .The finastride 5mg and 3mg , dutastride 0.5mg and 0.25mg and placebo tablets are identical in appearance and prepared by tansnim company . five treatment groups are labeled as A,B,C,D ,E by one of our collogues who is not care provider or assessor or data analyzer and each code represents one group and keep from the care provider and participants and assessor and data analyser until end of study. care provider and participants and data analyzer and outcome assessor are all blinded .Patients are assessed at visit 1 (screening visit) and If eligible, the patients will start in the double-blind study period where visits take place at weeks 4, 12, 24. a general physician who care for participants during trial is blinded in our study.

IPD collected for the primary and secondary outcome

when summary data are published

for people working in academic institutions

1- a new clinical trial is scheduled 2- affiliation of our center should be used

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