Unique ID issued by UMIN | UMIN000004454 |
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Receipt number | R000005331 |
Scientific Title | Effect of dutasteride for relieving benign prostatic obstruction |
Date of disclosure of the study information | 2010/10/26 |
Last modified on | 2017/01/21 11:56:08 |
Effect of dutasteride for relieving benign prostatic obstruction
AVO PFS Study
Effect of dutasteride for relieving benign prostatic obstruction
AVO PFS Study
Japan |
Benign Prostatic Hyperplasia
Urology |
Others
NO
To investigate the effect of dutasteride for relieving benign prostatic obstruction (BPO) by pressure flow study (PFS)
Efficacy
Change from baseline in PFS parameter
IPSS
OABSS
Urinary flow
Post voided residual volume
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Dutasteride 0.5mg/day for 24 months
50 | years-old | <= |
Not applicable |
Male
Subjects who meet all the following criteria will be enrolled.
1 Age >= 50 yrs
2 IPSS >= 8
3 IPSS QOL >= 3
4 Prostate volume >= 25mL measured by abdominal ultarsonograpy
5 Qmax < 15mL/sec
Subjects who apply to any of the following criteria will not be enrolled.
1 Use of any alpha-blocker within 4 weeks
2 Previous use of 5ARIs or antiandrogens
3 History of prostate cancer
4 History of acute urinary retention (AUR) within 3 months
5 Previous prostatic surgery
60
1st name | |
Middle name | |
Last name | Yoshihisa Matsukawa |
Nagoya University Graduate School of Medicine
Department of Urology
65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
+81-52-744-2985
1st name | |
Middle name | |
Last name | Yoshihisa Matsukawa |
Nagoya University Graduate School of Medicine
Department of Urology
65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
Department of Urology, Nagoya University School of Medicine
GlaxoSmithKline
Profit organization
Japan
NO
2010 | Year | 10 | Month | 26 | Day |
Partially published
Dutasteride was effective for relieving LUTS by improving storage and voiding function as well as subjective symptoms in patients with BPH.
Completed
2010 | Year | 07 | Month | 23 | Day |
2010 | Year | 08 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2010 | Year | 10 | Month | 26 | Day |
2017 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005331
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