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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025443
Receipt No. R000029283
Scientific Title Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

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Basic information
Public title Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Acronym Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Scientific Title Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Scientific Title:Acronym Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Region
Japan

Condition
Condition BPH
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cost-effectiveness of dutasteride
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group 1: dutasteride + tamsulosin
IPSS, VAS, uroflowmetry, PVR, and Prostate volume at week 1, 2, 4, 6, 8, 10, and 12
Interventions/Control_2 Group 2: tamsulosin only
IPSS, VAS, uroflowmetry, PVR, and Prostate volume at week 1, 2, 4, 6, 8, 10, and 12
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 BPH
IPSS 8 and more
Qmax 15 mL/s and more
Prostate volume 30 mL and more
Key exclusion criteria PSA 10ng/mL and more
Prostate cancer
Surgery for prostate in the last 3 months
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihide Hirayama
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email hirayamn@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohide Fujimoto
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email kiyokun@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2016 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2012 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029283

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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