UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000032846