UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009580 |
|---|---|
| Receipt number | 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 11:19:41 |
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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
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
k-fuku@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Urology
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011239
