UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000839 |
|---|---|
| Receipt number | R000001007 |
| Scientific Title | Randomized, double-blind, placebo-controlled crossover study of ejaculatory disorder caused by orally administered silodosin in healty volunteer men |
| Date of disclosure of the study information | 2007/10/01 |
| Last modified on | 2008/04/10 00:27:41 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled crossover study of ejaculatory disorder caused by orally administered silodosin in healty volunteer men
Acronym
Crossover study of ejaculatory disorder caused by silodosin
Scientific Title
Randomized, double-blind, placebo-controlled crossover study of ejaculatory disorder caused by orally administered silodosin in healty volunteer men
Scientific Title:Acronym
Crossover study of ejaculatory disorder caused by silodosin
Region
| Japan |
Condition
Condition
Japanese healthy volunteer men
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the quality of orgasm with and without ejaculatory disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Numerical Rating Scale(NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodosin (Wash-out) Placebo
Interventions/Control_2
Placebo (Wash-out) Silodosin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Men who are not disabled in ejaculating
Men who are not disabled in achieving an orgasm
Men who can refrain from drinking alcohol before ejaculation
Key exclusion criteria
Men who are taking alpha adrenergic receptor blockade
Men who have received transurethral resection of prostate (TUR-P)
Men who have retrograde ejaculation
Men who have received retroperitoneal lymph node dissection (RPLND)
Men who have been diagnosed erectile dysfunction (ED)
Men who have been diagnosed diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumitaka Shimizu |
Organization
Graduate school of medicine,
Juntendo University
Division name
Department of Urology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421 Japan
TEL
03-5802-1227
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumitaka Shimizu |
Organization
Graduate school of medicine, Juntendo University
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
fshimizu-jua@umin.ac.jp
Sponsor or person
Institute
Graduate school of medicine,
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2007 | Year | 10 | Month | 01 | 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
| 2007 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 30 | Day |
Last modified on
| 2008 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001007
