UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012394 |
|---|---|
| Receipt number | R000014497 |
| Scientific Title | Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2019/02/28 11:30:34 |
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Basic information
Public title
Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Acronym
Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Scientific Title
Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Scientific Title:Acronym
Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Region
| Japan |
Condition
Condition
Erectile Dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess intracavernous injections of prostaglandin E1 for erectile dysfunction at multicenter study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy of intracavernous injections of prostaglandin E1
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
prostaglandin E1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Obtaining of written informed consent
2) contraindication or unavailable of Phosophodiesterase5 inhibitor
3) Patienthad a good responce of PGE1-ICI
Key exclusion criteria
1) cases with diseases of dementia or mental disease
2) cases with past history of allergic reaction to medicine
3)Patients was deemed by the physician as inappropriate to attend.
4) priapism(past history, drepanocyte, eukemia,multiple myeloma )
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nagai |
Organization
Kawasaki medical school
Division name
Department of Urology
Zip code
Address
577 Matsushima Kurashiki, Okayama, Japan
TEL
086-462-1111
nagai@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nagai |
Organization
Kawasaki medical school
Division name
Department of Urology
Zip code
Address
577 Matsushima Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
nagai@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Urology, Kawasaki medical school
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
長野赤十字病院（長野県）
あらき腎・泌尿器科クリニック（岡山県）
岡山市立市民病院（岡山県）
聖隷浜松病院（静岡県）
慈愛会今村病院（鹿児島県）
名古屋市立大学（愛知県）
高松赤十字病院（香川県）
大阪市立大（大阪府）
中部労災病院（愛知県）
札幌医科大学（北海道）
獨協医科大学越谷病院（埼玉県）
昭和大学藤が丘病院（神奈川県）
三樹会病院（北海道）
順天堂大学浦安病院（千葉県）
筑波大学（茨城県）
原三信病院（福岡県）
大阪大学（大阪府）
東邦大学リプロダクションセンター（東京都）
東邦大学（東京都）
順天堂大学（東京都）
北海道済生会小樽病院（北海道）
平塚市民病院（神奈川県）
東京歯科大学市川総合病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | 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
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2013 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014497
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
