The efficacy and safety of the combination of terazosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized, active controlled, multi-center clinical trial

Kangdong Sacred Heart Hospital0 个研究点目标入组 124 人开始时间: 待定最近更新: 2019年12月16日

试验速览

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•1) Men over 45 years old
•2) Patients diagnosed with lower urinary tract symptoms due to benign prostatic hyperplasia
•3) Patients whose maximum urinary flow rate Qmax is from 5 to 15 mL/sec at Visit 2
•4) Patients who has minimum voided volume> 125mL at Visit 2
•5) Patients whose PSA(Prostate specific antigen) = 4.0ng/mL factor at Visit 1(except 4.0ng/mL is negative if biopsy results)
•6) Patients whose prostate hyperplasia has been confirmed by rectal examination at Visit 1
•7) Patients who has a fixed relationship with one female partner who can maintain a relationship during the examination
•8) Patients who can have sexual intercourse attempts at least 4 times during a four-week free run-in period, once per day on different days.
•9) After four weeks of free run-in, both of the following criteria are met:
•- Total IPSS score = 13 points
•- IIEF-EF domain = 24 points, and items 3 and 4 of IIEF are 3 points
•10) Patients who understand the clinical trial's process and signed the consent voluntarily

•1) Patients have other conditions that can cause lower urinary tract symptoms other than prostatic hyperplasia: prostate cancer, lower urinary tract cancer, including bladder cancer, neurogenic bladder, lower urinary tract infection, urethral stricture, bladder stenosis neck contracture, prostatitis, etc.
•2) Patients who have a PVR (post void residual volume) measured at Visit 2 300mL or more.
•3) Patients had or have suspected orthostatic hypotension, dizziness, dizziness, loss of consciousness, fainting.
•4) Patients who have undergone surgery on the Urinary tract, such as the prostate, urethra, or bladder, or invasive to the prostate for the treatment of other prostates, or who have been planned during clinical trials.
•5) Patients who have an anatomic malformation of the penis or have a history of penile anorexia due to medication.
•6) Patients who have had pelvic surgery within 6 months before screening.
•7) Patients with hypersensitivity to the components of the study drug or sulfa drug.
•8) Patients who had acute urinary retention within 4 weeks prior to screening.
•9) Patients currently suspected or diagnosed with lower urinary tract stones or bladder stones.
•10) Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
•11) Patients with uncontrolled diabetics.

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