UMIN ID: UMIN000002126
Registered date:26/06/2009
Clinical effect of Eviprostat in patients with high levels of PSA
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | patients with high levels of PSA |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Three tablets of Eviprostat three times per day for 12 months no medication |
Outcome(s)
| Primary Outcome | Histological changes of prostate inflammation in prostate biopsy will be examined between before and after the intake of Eviprostat for 12 months. Inflammation is assessed across all scores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3). |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1) patients with prostate cancer 2) patients with previous operation on prostate 3) Subjects taking any anti-androgen drugs 4) patients with prostatitis 5) Subjects with active urinary infection 6) Subjects with urethral catheter 7) Subjects with irritation to Eviprostat 8) Severe renal dysfunction 9) Severe liver dysfunction 10) Other ineligible subjects |
Related Information
| Primary Sponsor | Department of Urology, University of Tokyo Hospita |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Urology, University of Tokyo Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroshi Fukuhara |
| Address | Japan |
| Telephone | |
| Affiliation | University of Tokyo Hospital Department of Uology |
| scientific contact | |
| Name | Hiroshi Fukuhara |
| Address | 7-3-1 Hongo, Bunkyo-ku Tokyo Japan |
| Telephone | |
| Affiliation | University of Tokyo Hospital Department of Uology |