UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
Title of the study (Brief title)	A clinical for evaluating the effect of L-citrulline on erectile dysfunction and dysuria
Region	Japan

Condition
Condition	Benign Prostatic Hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of L-citrulline and PDE5 inhibitor intake for 8weeks on the function of corpus cavernosum and dysuria
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Erectile function (IIEF,EHS)
Key secondary outcomes	IPSS,OABSS,frequency volume chart,UFM,residual urine,SEP2, SEP3, GAQ,VAS,blood biochemistry

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of L-citruline for 8weeks
Interventions/Control_2	Intake of placebo for 8weeks
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	45 years-old <=
Age-upper limit	75 years-old >=
Gender	Male
Key inclusion criteria	1.Subject aged from 45 to 75 years 2.Subject taking PDE5 inhibitor for 4weeks to treat Benign Prostatic Hyperplasia. 3.Subject classified IIEF score 8 to 25 4.Subject having sexual intercourse at least once a 8 week.
Key exclusion criteria	1.Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders 2.Subject having a neurological disease 3.Subject having penile organic dysfunction 4.Subject having endocrine disease 5.Subject injecting insulin 6.Subject receiving hormone replacement therapy 7.Subject diagnosed psychogenic ED 8.Subject having the habit of taking a L-citrulline 9.Subject judged to be ineligible by the investigator for other reason
Target sample size	40

Research contact person
Name of lead principal investigator	Kazunori Kimura
Organization	Graduate School of Medical Sciences, Nagoya City University
Division name	Department of Clinical Pharmacy
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Email	kkimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Kazunori Kimura
Organization	Graduate School of Medical Sciences, Nagoya City University
Division name	Department of Clinical Pharmacy
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Homepage URL
Email	kkimura@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Funding Source
Organization	KYOWA HAKKO BIO CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 08 Day
Anticipated trial start date	2015 Year 01 Month 04 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 24 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018654