Main
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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:
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JPRN |
Last refreshed on:
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17 October 2023 |
Main ID: |
JPRN-UMIN000016050 |
Date of registration:
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25/12/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
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Scientific title:
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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:
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2015/01/04 |
Target sample size:
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40 |
Recruitment status: |
Complete: follow-up complete |
URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018654 |
Study type:
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Interventional |
Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazunori Kimura |
Address:
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1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Japan |
Telephone:
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052-851-5511 |
Email:
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kkimura@med.nagoya-cu.ac.jp |
Affiliation:
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Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy |
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Name:
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Kazunori Kimura |
Address:
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1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Japan |
Telephone:
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052-851-5511 |
Email:
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kkimura@med.nagoya-cu.ac.jp |
Affiliation:
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Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia
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Intervention(s)
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Intake of L-citruline for 8weeks Intake of placebo for 8weeks
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Primary Outcome(s)
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Erectile function (IIEF,EHS)
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Secondary Outcome(s)
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IPSS,OABSS,frequency volume chart,UFM,residual urine,SEP2, SEP3, GAQ,VAS,blood biochemistry
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Source(s) of Monetary Support
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KYOWA HAKKO BIO CO., LTD
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/11/2017 |
URL:
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