UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028695
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email masatos@juntendo-urayasu.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.