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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004454
Receipt No. 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

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Basic information
Public title Effect of dutasteride for relieving benign prostatic obstruction
Acronym AVO PFS Study
Scientific Title Effect of dutasteride for relieving benign prostatic obstruction
Scientific Title:Acronym AVO PFS Study
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of dutasteride for relieving benign prostatic obstruction (BPO) by pressure flow study (PFS)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline in PFS parameter
Key secondary outcomes IPSS
OABSS
Urinary flow
Post voided residual volume
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dutasteride 0.5mg/day for 24 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 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


Key exclusion criteria 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL +81-52-744-2985
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL +81-52-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Department of Urology, Nagoya University School of Medicine
Institute
Department

Funding Source
Organization GlaxoSmithKline
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 
Dutasteride was effective for relieving LUTS by improving storage and voiding function as well as subjective symptoms in patients with BPH.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 01 Month 01 Day
Date trial data considered complete
2013 Year 01 Month 01 Day
Date analysis concluded
2014 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 26 Day
Last modified on
2017 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005331

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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