UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028695 |
|---|---|
| Receipt number | R000032846 |
| Scientific Title | Oral L-citrulline and Transresveratrol supplementation study for erectile function in men with phosphodieserase 5 inhibitors: randomized, double-blind, placebo-controlled crossover pilot study. |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2019/03/13 21:37:33 |
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Basic information
Public title
Oral L-citrulline and Transresveratrol supplementation study for erectile function in men with phosphodieserase 5 inhibitors: randomized, double-blind, placebo-controlled crossover pilot study.
Acronym
L-citrulline and Transresveratrol supplementation study for erectile function.
Scientific Title
Oral L-citrulline and Transresveratrol supplementation study for erectile function in men with phosphodieserase 5 inhibitors: randomized, double-blind, placebo-controlled crossover pilot study.
Scientific Title:Acronym
L-citrulline and Transresveratrol supplementation study for erectile function.
Region
| Japan |
Condition
Condition
Erectile Dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving erectile function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sexual Health Inventory for Men
Key secondary outcomes
Erection Hardness Score
Aging Male Scale (Sexual Domain)
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral L-citrulline and Transresveratrol 4-week supplementation
Interventions/Control_2
Oral placebo 4-week
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
Score below 16 of Sexual Health Inventory for Men, despite on-demand use of PDE5i
Key exclusion criteria
Contraindication for PDE5i
Without nerve sparing, radical prostatectomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Shirai |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Urology
Zip code
2790021
Address
2-1-1, Tomioka, Urayasu City, Chiba, Japan
TEL
+81-47-353-3111
masatos@juntendo-urayasu.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Shirai |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Urology
Zip code
2790021
Address
2-1-1, Tomioka, Urayasu City, Chiba, Japan
TEL
+81-47-353-3111
Homepage URL
masatos@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
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
Men's health clinic, Tokyo
Oosaka University
Iwasa clinic
Kageyama clinic
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional Review Board, Juntendo University Urayasu Hospital
Address
2-1-1, Tomioka, Urayasu City, Chiba, Japan
Tel
+81-47-353-3111
rinri-urayasu@juntendo-urayasu.jp
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
順天堂大学浦安病院（千葉県）Juntendo University Urayasu Hospital
メンズヘルスクリニック東京（東京都）Men’s health clinic, Tokyo
大阪大学（大阪府） Oosaka University
岩佐クリニック （大阪府）Iwasa clinic
かげやま医院 （静岡県）Kageyama clinic
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 18 | 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
20
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
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032846
