UMIN ID: UMIN000016050
Registered date:25/12/2014
A clinical for evaluating the effect of L-citrulline and PDE5 inhibitor on erectile dysfunction and dysuria
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Benign Prostatic Hyperplasia |
| Date of first enrollment | 2015/01/04 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Intake of L-citruline for 8weeks Intake of placebo for 8weeks |
Outcome(s)
| Primary Outcome | Erectile function (IIEF,EHS) |
|---|---|
| Secondary Outcome | IPSS,OABSS,frequency volume chart,UFM,residual urine,SEP2, SEP3, GAQ,VAS,blood biochemistry |
Key inclusion & exclusion criteria
| Age minimum | 45years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Nagoya City University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | KYOWA HAKKO BIO CO., LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazunori Kimura |
| Address | 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan |
| Telephone | 052-851-5511 |
| kkimura@med.nagoya-cu.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy |
| scientific contact | |
| Name | Kazunori Kimura |
| Address | 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan |
| Telephone | 052-851-5511 |
| kkimura@med.nagoya-cu.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Nagoya City University Department of Clinical Pharmacy |