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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009580
Receipt No. R000011239
Scientific Title Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Date of disclosure of the study information 2013/01/01
Last modified on 2017/10/18

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Basic information
Public title Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Acronym Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Scientific Title Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Scientific Title:Acronym Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Region
Japan

Condition
Condition benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effectiveness for endothelial function after administration of tadarafil for men with urinary and sexual symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the vascular endothelial function before and after recieved tadalafil at 5mg a day 12 weeks.
Key secondary outcomes

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 recieved tadalafil at once a day morning during 3 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 Even if received alfa blocker over 4 weeks, IPSS score was over 8 points and QOL index was over 2 points.
Key exclusion criteria 1 Patients Received nitrate drug
2 Patients has organic disease other than BPH, that was prostate cancer,bladder tumor, bladder stone, prostatitis, urethral stenosis et al.
3 Patients were performed urological surgery before 6 months.
4 Patients have active urinary infection.
5 Patients has neurogenic bladder.
6 Patients has severe ischemic coronary disease, cerebrovascular accident, liver dysfunction, renal dysfunction.
7 Patients has hypotension.
8 Doctor has other patients deemed inappropriate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko fukumoto
Organization Kawasaki Medical School
Division name urology
Zip code
Address 577 Matsushima Kurashiki, Okayama, Japan
TEL 096-462-1111
Email k-fuku@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko
Organization Kawasaki medical school
Division name Urology
Zip code
Address 577 Matsushima Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email k-fuku@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Urology
Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Urology
Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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 川崎医科大学(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 11 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
2012 Year 12 Month 19 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011239

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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