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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000016050
Date of registration: 25/12/2014
Prospective Registration: Yes
Primary sponsor: Nagoya City University Hospital
Public title: A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
Scientific title: A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria - A clinical for evaluating the effect of L-citrulline on erectile dysfunction and dysuria
Date of first enrolment: 2015/01/04
Target sample size: 40
Recruitment status: Complete: follow-up complete
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018654
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:     Kazunori Kimura
Address:  1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
Telephone: 052-851-5511
Email: kkimura@med.nagoya-cu.ac.jp
Affiliation:  Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy
Name:     Kazunori Kimura
Address:  1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
Telephone: 052-851-5511
Email: kkimura@med.nagoya-cu.ac.jp
Affiliation:  Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy
Key inclusion & exclusion criteria
Inclusion criteria:
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

Age minimum: 45years-old
Age maximum: 75years-old
Gender: Male
Health Condition(s) or Problem(s) studied
Benign Prostatic Hyperplasia
Intervention(s)
Intake of L-citruline for 8weeks
Intake of placebo for 8weeks
Primary Outcome(s)
Erectile function (IIEF,EHS)
Secondary Outcome(s)
IPSS,OABSS,frequency volume chart,UFM,residual urine,SEP2, SEP3, GAQ,VAS,blood biochemistry
Secondary ID(s)
Source(s) of Monetary Support
KYOWA HAKKO BIO CO., LTD
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available: Yes
Date Posted:
Date Completed: 30/11/2017
URL:
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